HOUSE DUST

ALK-Abello, Inc.

Allergenic Extracts For Diagnostic Use Only

FULL PRESCRIBING INFORMATION

ALLERGENIC EXTRACTS, FOR DIAGNOSTIC USE ONLY

DIRECTIONS FOR USE

Sterile diagnostic extracts are supplied in either phenol-saline diluent for Intradermal Testing or in diluent containing glycerin 50% (v/v) for Percutaneous Testing and phenol 0.4% (preservative). Inactive ingredients may include: sodium chloride for isotonicity, glycerin, and sodium bicarbonate as a buffer. Inactive ingredients in mold extracts may include residual potassium phosphate, and calcium carbonate from growth media.

Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and after final packaging, they are tested for sterility and safety.

House Dust, a heterogenous, widely distributed allergen, is among the most frequently encountered as a primary or accompanying cause of allergic symptoms. Allergic inhalants found in house dust include mites, insects, mold spores, feathers, animal dander, pollens, hairs, food and cleansing agent residues. Individual environs may contain certain items not ordinarily found so that a stock house dust extract may not elicit a response on testing. House Dust Extracts are prepared from dust collected from homes and from establishments which clean household rugs. It is extracted from buffered, aqueous extracting fluid. House Dust Extract is dialyzed, filtered aseptically, and after final packaging is tested for sterility and safety.

Molds (fungi) are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Mold extracts are extracted in a phenol preserved saline solution. The extract is dialyzed, filtered aseptically and after final packaging is tested for sterility and safety.

Foods, miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.

Diagnostically (for skin testing), the allergen combines with IgE antibodies fixed to mast cells in the skin. This complexing causes an increase in cellular permeability and degranulation of the mast cells releasing chemical mediators. These mediators (such as histamine) are responsible for a local inflammatory response of wheal and erythema typical of a positive skin test reaction and also, the symptoms commonly associated with allergic disease.¹ The more mediator release, the larger the reaction (wheal and erythema).

These products are for diagnostic use only. Diagnostic allergenic extracts are indicated for use in skin testing to establish the clinical relevance of specific allergens to which the patient has been exposed. By measuring skin test response the physician may assess the degree of sensitivity that patients have to the allergens. For extracts standardized in AU and BAU, see individual directions for use.  Allergenic extracts for diagnostic use only of coffee, mosquito, cottonseed, and flaxseed have not been shown by adequate data to be safe and effective for therapeutic use.

Patients on beta blockers can be non-responsive to beta agonists that may be required to reverse a systemic reaction (also, see boxed WARNINGS statement and ADVERSE REACTIONS ). The physician should carefully weigh the benefit derived from skin testing vs. the risk to the patient should a systemic reaction arise.

Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk to a fatal outcome from a systemic allergic reaction^{2 , 3 .} See also  PRECAUTIONS and ADVERSE REACTIONS .

Patients should always be observed for at least 20 - 30 minutes after skin testing. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstruction, hypotension, coma and death (see ADVERSE REACTIONS ), applications of a tourniquet above the injection site and administration of 0.2 mL to 1 mL (0.01 mg/kg) of epinephrine injection (1:1,000) are recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released at 15 minute intervals. Patients under treatment with beta blockers may be refractory to the usual dose of epinephrine.

Volume expanders and vasopressor agents may be required to reverse hypotension, inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In case of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation.

Patients should be instructed to describe any active allergic symptoms such as rhinitis, wheezing, dyspnea, etc. prior to testing. Also, see ADVERSE REACTIONS  and WARNINGS  Sections.

Patients should always be observed 20 to 30 minutes after testing.

• In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications for skin testing must be weighed carefully against the risk of temporarily aggravating the symptoms by the testing itself. Objective assessment of pulmonary function such as Peak Expiratory Flow Rate (PEFR) before allergen administration and prior to discharge may be useful in unstable asthmatics to reduce the chances of exacerbation of the patient’s asthma. Patients should be instructed to describe any active allergic symptoms as described above prior to skin testing and encouraged to report any late reactions from this testing. Also, see ADVERSE REACTIONS  and WARNINGS sections.
  
• Store allergenic extracts between 2^o - 8^o C at all times, even during use.
  
• Care must be taken to avoid drawing blood.
  • For percutaneous testing, if blood is observed, immediately wipe the allergen from the site.
    
  • For intradermal skin testing, pull gently on the syringe plunger and note if any blood enters the syringe. If blood is obtained, reposition the needle and repeat before injecting (see DOSAGE AND ADMINISTRATION ).
  
  
• Allergenic extracts become less potent with age. Allergenic extracts containing glycerin 50% v/v are relatively stable. Non-glycerinated aqueous extracts, particularly dilute forms as used for intradermal skin testing, have been shown to be extremely unstable. Until such time as stability studies are complete with dilute allergens, new intradermal strength materials should be prepared every few weeks.
  
• Use standard aseptic precautions if making dilutions from stock concentrates to intradermal strength.
  
• For intradermal testing: Extracts in glycerin 50% v/v must be diluted with a non-glycerinated diluent and must be diluted at least 25-fold to less than 2% glycerin by volume, as glycerin above this level can cause false positive intradermal skin test results.

Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Controlled studies of hyposensitization with moderate to high doses of allergenic extracts during conception and all trimesters of pregnancy have failed to demonstrate any risk to the fetus or to the mother⁴. However, on the basis of histamine's known ability to contract the uterine muscle, the release of significant amounts of histamine from allergen exposure to skin test overdose should be avoided on theoretical grounds. Therefore, allergenic extracts should be used cautiously in a pregnant woman and only if clearly needed.

Allergenic extracts for diagnostic use have been given safely in infants and young children. Infants have lower skin test reactivity to histamine, as well as common allergens. Skin test reactivity gradually increases to age 6 and plateaus to age 60. Therefore, small skin test reactions should be anticipated in children under age 6.

Skin test reactivity gradually decreases after age 60. Therefore, smaller skin test reactions should be anticipated in adults over age 60.

It is not known if allergens administered subcutaneously appear in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

Studies in animals have not been performed.

Drugs can interfere with the performance of skin tests⁵.

Antihistamines: Response to mediator (histamine) released by allergens is suppressed by antihistamines. The length of suppression varies and is dependent on individual patient, type of antihistamine and length of time the patient has been on antihistamines. The duration of this suppression may be as little as 24 hours (chlorpheniramine), and can be as long as 40 days (astemizole).

      Tricyclic Antidepressants: These exert a potent and sustained decrease of skin reactivity to histamine which may last for a few weeks.

      Beta₂ Agonists: Oral terbutaline and parenteral ephedrine, in general, have been shown to decrease allergen induced wheal.

      Dopamine: Intravenous infusion of dopamine may inhibit skin test responses.

      Beta Blocking Agents: Propanolol can significantly increase skin test reactivity.

      Other Drugs: Short acting steroids, inhaled beta₂ agonists, theophylline and cromolyn do not seem to affect skin test response.

Fatalities from skin testing in the United States have been extensively reviewed by Lockey.² Six fatalities were associated with intradermal testing without previous percutaneous testing and one was associated with a combination of percutaneous (scratch) and intradermal skin testing. With careful attention to dosage and administration, fatal reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and overdosage could result in anaphylactic symptoms. Therefore it is imperative that physicians administering allergenic extracts for skin testing understand, and be prepared for the treatment of severe reactions.

Local: Immediate wheal and erythema reactions are to be expected; but if very large, may be the first manifestation of a systemic reaction. In such cases, immediately wipe the test site(s) with sterile gauze or cotton to remove excess allergen.

Systemic Reactions: Systemic reactions are characterized by one or more of the following symptoms: sneezing, mild to severe generalized urticaria, itching (other than at the skin test site), extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, hypotension, syncope, and upper airway obstruction. Symptoms may progress to shock and death. Patients should always be observed for at least 20 - 30 minutes after testing.

Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalational bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. Severe airway obstruction unresponsive to bronchodilator may require tracheal intubation and use of oxygen. In the event of a marked systemic reaction, application of a tourniquet above the injection site and the administration of 0.02 mL to 1.0 mL of epinephrine injection (1:1,000) is recommended. Maximum recommended dose for children between 2 and 12 years of age is 0.3 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes.

Adverse events should be reported via MedWatch (1-800-FDA-1088). Adverse experience Reporting, HFM-210 Center for Biologics Evaluation & Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.

Signs and symptoms of overdose are typically large local and systemic reactions. For management of overdose reactions, refer to the ADVERSE REACTIONS section above.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Skin test techniques for immediate (Type I) hypersensitivity testing fall into two major categories: percutaneous, and intracutaneous.

Percutaneous techniques: For percutaneous testing, in general, skin is scratched, punctured or pricked just before the allergen is applied or through a drop of test allergen. There are several devices available for this technique. Refer to the manufacturer or distributor's circular for specific directions for their use.

In General:

• It is recommended that the test areas should be placed no closer than 4 - 5 cm apart to avoid interference of reactions when several tests are applied.
  
• Skin test areas should be cleansed with alcohol and air dried.
  
• Preferably, the allergen should be placed on the volar surface of the forearm, upper arm, or the patient's back. The patient should be placed in a comfortable position prior to testing.
  
• For scratch testing, a sharp, clean, sterile instrument is used to abrade the skin, but not to draw blood. Each scratch should be about 2 - 4 mm in length. A small drop of extract is placed on the surface of the skin.
  
• Prick testing: For prick testing, a sharp, sterile instrument is used to puncture the skin slightly, applying it at a 15 - 20^o angle to the skin. The instrument is gently raised, "tenting” the skin until it pops out, generally pricking through the drop of allergen. Do not draw blood.
  
• For puncture testing, a sharp, clean, sterile instrument must be used. Puncture the skin, through the drop of allergen, perpendicular to the skin. Do not draw blood.

For all of the above techniques, a separate instrument must be used for each patient; if the instrument is to be used to pass through the allergen, to avoid cross-contamination, a separate instrument is to be used for each allergen. The test should be read in 15 minutes, measuring both wheal size and erythema.

Intracutaneous (intradermal) testing: General: Intradermal testing is more sensitive than percutaneous testing and its specificity is dependent on dose. Intradermal testing is not intended as an initial screen unless used in highly dilute solutions. Intradermal testing is usually reserved for allergens that have demonstrated either negative or equivocal percutaneous skin test response in the face of positive or unclear history.

Intradermal testing of one allergen in several serial dilutions (beginning with the weakest to the more concentrated dilutions) may also be useful in assessing degree of patient sensitivity for the establishment of a safe starting dose for immunotherapy.

Bulk extracts must be diluted for intradermal testing. Use of Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA (albumin saline) is recommended. Dilutions should be made with sterile disposable syringes using aseptic technique. Commonly, 10 fold dilutions are used to achieve a desired concentration for intradermal testing and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 PNU/mL extract into 4.5 mL of diluent will yield 5 mL of extract at 1,000 PNU/mL. For weight volume products, a 1:100 w/v dilution may be prepared from a 1:10 w/v by transferring 0.5 mL of the 1:10 w/v to 4.5 mL of diluent. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration. As a general rule intradermal strength should begin at no higher than 1/100 to 1/1000 of the percutaneous strength that resulted in a negative skin test reaction.

• It is recommended that the test areas should be spaced no less than 5 cm apart to avoid interference with adjacent allergen or control.
  
• Skin should be cleansed with alcohol and air dried.
  
• A sterile 1 mL or ½ mL syringe with a 26 - 30 gauge needle should be used. A separate sterile syringe should be used for each extract and each patient.
  
• Care should be taken to eliminate air bubbles from the syringe prior to injecting the test dose. It is suggested that not more than 6 - 10 allergens of each different type be used at any one time. Very sensitive patients may show rapid response.
  
• The skin is held tensely, and the needle is inserted almost parallel to the skin, beveled side up far enough to cover the beveled portion. Slowly inject sufficient extract to make a small bleb of approximately 5 mm in diameter (0.01 - 0.02 mL).
  
• Read the test results in 15 minutes.

Selection of the proper strength for intracutaneous testing: A general rule for the prevention of untoward reactions, particularly in extremely sensitive patients, is to screen by percutaneous methods initially, and begin intradermal testing at a strength not more than 1/100 of a negative or equivocal percutaneous reaction.

Controls: In both percutaneous and intracutaneous tests, a negative control test with diluent alone should be performed because some patients exhibit dermographia, and/or other non-specific irritant responses.

As a positive control in the evaluation of allergenic skin testing, histamine 1 mg/mL (histamine base) should be used for percutaneous testing, and histamine 0.1 mg/mL (histamine base) should be used for intradermal testing.

Interpretation of results: Patient's response is graded on the basis of the size of erythema or wheal.⁶ General guidelines follow for percutaneous testing, different devices and/or techniques influence the size of the reaction, therefore it is important to refer to the device manufacturer's or distributor's instructions when grading reactions.

Percutaneous (prick or scratch) test:

0	No reaction or less than control.
+	Erythema greater than control, smaller than a nickel (21 mm diameter).
++	Erythema greater than a nickel in diameter, no wheal.
+++	Wheal and erythema without pseudopods.
++++	Wheal and erythema with pseudopods.

Intradermal test:

0	No reaction or less than negative control.
+	3-4 mm wheal with erythema, or erythema alone larger than a nickel (21 mm diamether).
++	4-8 mm wheal and erythema, without pseudopods.
+++	Over 8 mm wheal and erythema without pseudopods
++++	Wheal and erythema with pseudopods.

For scratch and prick testing: 5 mL dropper applicator vials in 50% v/v glycerin. Available individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v).

For intracutaneous testing: 5 mL sterile vials, aqueous based, individually and in a complete set of the most common allergens. Available in either Protein Nitrogen Units (PNU/mL) or weight to volume (w/v).

Histatrol ^R Positive skin test control - histamine. 1 mg/mL and 0.1 mg/mL histamine base.

See Product Catalog for specific diagnostic concentrations available.

To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2^o to 8^o C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.

• Holgate, S.T., Robinson, C. and Church, M.K., Mediators of immediate hypersensitivity. In Middleton et al: Allergy Principles and Practice, St. Louis, 1988, C.V. Mosby, p 135.
  
• Lockey, R.F., et al, Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol., 1987:79:660.
  
• Reid, M.J. et al.  Survey of fatalities from skin testing and immunotherapy. 1985-1989. J. Allergy Clin Immunol. 1993; 92:6.
  
• DeBuske L. M. et al.  Special problems regarding Allergen Immunotherapy in Immunology and Allergy Clinics of North America. Greenburger, P.A. Ed. February 1992; 145-149.
  
• Bousquet, J. In vivo methods for the study of allergy: skin test, techniques and interpretation. In: Middleton et al.: Allergy Principles and Practice 3 ^rd Ed. St. Louis: DV Mosby, 1988:167.
  
• Freedman, S.O., Asthma and Allergic Rhinitis II. Clinical Aspects, in Freedman and Gold Clinical Immunology 2nd Ed. New York: Harper & Row, 1976:131.

Revision: June 2002

©ALK-Abello, Inc.                                                 112N

Distributed in Canada by:

Western Allergy Services, LTD.

121-6154 Westminister Highway

Richmond, B.C. V7C404

HOUSE DUST House Dust INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6000 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST HOUSE DUST 10000 [PNU] Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6000-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ALMOND Almond Food INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6100 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALMOND 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6100-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

APPLE Apple Food INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6101 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APPLE 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6101-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

APRICOT Apricot INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6102 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APRICOT 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6102-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ASPARAGUS Asparagus INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6103 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPARAGUS ASPARAGUS 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6103-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

AVOCADO Avocado INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6104 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOCADO 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6104-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BANANA Banana INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6105 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BANANA 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6105-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BARLEY Barley Food INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6106 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARLEY BARLEY 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6106-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BEAN Pinto Bean Kidney Bean INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6107 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BEAN Bean 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6107-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

STRING BEAN String Bean Green Bean INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6108 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRING BEAN String Bean 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6108-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BEEF Beef INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6109 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BEEF Beef 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6109-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BRAZIL NUT Brazil Nut INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6110 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRAZIL NUT Brazil Nut 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6110-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BROCCOLI Broccoli INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6112 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROCCOLI BROCCOLI 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6112-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BUCKWHEAT Buckwheat INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6113 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUCKWHEAT BUCKWHEAT 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6113-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CABBAGE Cabbage INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6114 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CABBAGE 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6114-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CANTALOUPE Cantaloupe INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6115 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANTALOUPE Cantaloupe 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6115-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CARROT Carrot INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6116 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARROT 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6116-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CASEIN Casein INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6118 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASEIN Casein 0.01 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6118-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CELERY Celery INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6120 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELERY Celery 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6120-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CHERRY Cherry INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6121 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHERRY 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6121-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CHICKEN Chicken Meat INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6122 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHICKEN 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6122-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CINNAMON Cinnamon INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6123 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CINNAMON 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6123-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CLAM Clam INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6124 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLAM CLAM 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6124-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

COCOA BEAN Cocoa Bean Whole Bean Chocolate INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6125 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BEAN COCOA BEAN 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6125-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

COCONUT Coconut INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6127 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCONUT 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6127-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CODFISH Codfish INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6128 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODFISH CODFISH 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6128-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

COFFEE BEAN Coffee INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6129 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COFFEE BEAN COFFEE BEAN 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6129-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CRAB Crab INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6130 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CRAB CRAB 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6130-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CUCUMBER Cucumber INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6132 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUCUMBER 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6132-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

EGG WHITE Egg White INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6133 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG WHITE Egg White 0.01 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6133-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

EGG Whole Egg INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6135 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG EGG 0.01 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6135-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

EGG YOLK Egg Yolk INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6136 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG YOLK Egg Yolk 0.01 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6136-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

FLOUNDER Flounder INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6137 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLOUNDER FLOUNDER 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6137-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

GARLIC Garlic INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6138 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GARLIC Garlic 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6138-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

GRAPE White Seedless Grape INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6139 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GRAPE 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6139-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

GRAPEFRUIT Grapefruit INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6141 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GRAPEFRUIT 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6141-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

KARAYA GUM Karaya Gum Bassora INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6143 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Karaya Gum KARAYA GUM 0.005 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6143-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

HONEYDEW MELON Honeydew INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6146 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HONEYDEW MELON HONEYDEW MELON 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6146-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

LAMB Lamb INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6149 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMB LAMB 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6149-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

LEMON Lemon INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6170 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEMON 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6170-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

LETTUCE Lettuce INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6171 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LETTUCE LETTUCE 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6171-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

LIMA BEAN Lima Bean INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6173 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIMA BEAN 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6173-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

LOBSTER Lobster INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6174 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOBSTER LOBSTER 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6174-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

GOAT MILK Goat Milk INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6177 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GOAT MILK 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6177-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

COW MILK Milk Whole Cows INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6178 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COW MILK COW MILK 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6178-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

MUSHROOM Mushroom Agaricus spp INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6180 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CULTIVATED MUSHROOM 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6180-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

MUSTARD SEED Mustard Seed INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6181 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUSTARD SEED MUSTARD SEED 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6181-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

OAT Oat Grain INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6183 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OAT 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6183-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BLACK OLIVE Olive INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6185 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK OLIVE 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6185-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ONION Onion INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6186 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION ONION 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6186-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ORANGE Orange INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6187 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ORANGE 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6187-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

OYSTER Oyster INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6189 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OYSTER OYSTER 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6189-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PEA Green Pea English INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6191 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEA 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6191-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PEACH Peach INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6192 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEACH Peach 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6192-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PEANUT Peanut INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6193 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEANUT Peanut 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6193-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PEAR Pear INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6195 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEAR 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6195-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PECAN Pecan INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6196 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECAN Pecan 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6196-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

GREEN BELL PEPPER Bell INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6197 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GREEN BELL PEPPER Green Bell Pepper 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6197-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BLACK PEPPER Black Pepper INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6198 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK PEPPER BLACK PEPPER 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6198-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PINEAPPLE Pineapple INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6200 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINEAPPLE PINEAPPLE 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6200-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PISTACHIO Pistachio Nut INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6202 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PISTACHIO PISTACHIO 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6202-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PLUM Plum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6203 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLUM PLUM 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6203-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PORK Pork INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6204 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PORK Pork 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6204-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

POTATO Sweet Potato INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6205 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTATO Potato 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6205-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

POTATO White Potato INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6206 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTATO Potato 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6206-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

RICE Rice INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6208 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RICE RICE 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6208-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

RYE Rye INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6210 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RYE 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6210-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

SALMON Salmon INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6212 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALMON SALMON 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6212-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

SESAME SEED Sesame Seed INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6213 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SESAME SEED SESAME SEED 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6213-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

SHRIMP Shrimp INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6214 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SHRIMP SHRIMP 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6214-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

SOYBEAN Soybean INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6216 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOYBEAN 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6216-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

SPINACH Spinach INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6218 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPINACH SPINACH 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6218-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

SQUASH Squash INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6219 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SQUASH SQUASH 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6219-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

STRAWBERRY Strawberry INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6220 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Strawberry 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6220-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CORN Sweet Corn INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6221 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORN 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6221-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

TOMATO Tomato INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6224 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOMATO 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6224-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

TUNA Tuna INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6226 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TUNA TUNA 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6226-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

TURKEY Turkey Meat INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6229 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TURKEY TURKEY 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6229-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

VANILLA Vanilla INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6230 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VANILLA 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6230-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ENGLISH WALNUT English Walnut INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6231 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENGLISH WALNUT English Walnut 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6231-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

WATERMELON Watermelon INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6233 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATERMELON 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6233-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

WHEAT Whole Wheat Wheat Grain INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6234 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WHEAT WHEAT 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6234-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BOS TAURUS SKIN Cattle Epithelium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6300 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS SKIN BOS TAURUS SKIN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6300-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

COTTON FIBER Cattle Epithelium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6302 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON FIBER COTTON FIBER 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6302-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

COTTON SEED Cottonseed INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6304 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON SEED 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6304-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CANIS LUPUS FAMILIARIS SKIN Dog Epithelium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6306 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN CANIS LUPUS FAMILIARIS SKIN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6306-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CAVIA PORCELLUS SKIN Guinea Pig Epithelium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6309 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAVIA PORCELLUS SKIN CAVIA PORCELLUS SKIN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6309-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

EQUUS CABALLUS SKIN Horse Epithelium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6311 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN EQUUS CABALLUS SKIN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6311-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

CEIBA PENTANDRA FIBER Kapok INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6312 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEIBA PENTANDRA FIBER CEIBA PENTANDRA FIBER 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6312-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

MUS MUSCULUS SKIN Mouse Epithelium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6314 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUS MUSCULUS SKIN MUS MUSCULUS SKIN 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6314-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ORRIS Orris Root INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6317 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ORRIS ORRIS 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6317-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PYRETHRUM CINERARIIFOLIUM Pyrethrum INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6318 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRETHRUM CINERARIIFOLIUM PYRETHRUM CINERARIIFOLIUM 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6318-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

RABBIT Rabbit Epithelium INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6320 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RABBIT RABBIT 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6320-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

SOLENOPSIS INVICTA Fire Ant INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6400 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLENOPSIS INVICTA Solenopsis invicta 0.01 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6400-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

PERIPLANETA AMERICANA American Cockroach INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6403 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA PERIPLANETA AMERICANA 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6403-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

BLATELLA GERMANICA German Cockroach INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6405 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA BLATELLA GERMANICA 0.05 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6405-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ACREMONIUM STRICTUM ACREMONIUM STRICTUM INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6500 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACREMONIUM STRICTUM Acremonium strictum 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6500-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ALTERNARIA TENUIS Alternaria tenuis A alternata INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6502 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA ALTERNARIA ALTERNATA 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6502-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ASPERGILLUS FUMIGATUS Aspergillus Fumigatus INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6504 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6504-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01

ASPERGILLUS NIGER VAR NIGER Aspergillus Niger INJECTION, SOLUTION Product Information Product Type Non-standardized allergenic label Item Code (Source) NDC:0268-6507 Route of Administration PERCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER Aspergillus Niger Var. Niger 0.10 g Inactive Ingredients Ingredient Name Strength GLYCERIN PHENOL SODIUM CHLORIDE SODIUM BICARBONATE HYDROCHLORIC ACID SODIUM HYDROXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-6507-06 5 in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 1965-01-01