Sodium Sulfacetamide 10 Sulfur 5

Acella Pharmaceuticals, LLC

Sodium Sulfacetamide 10% - Sulfur 5%

FULL PRESCRIBING INFORMATION: CONTENTS*

• PRINCIPAL DISPLAY PANEL - 3.7 Box

FULL PRESCRIBING INFORMATION

Facial Cleansing Cloths

Rx Only

DESCRIPTION: Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

Each cloth of Sodium Sulfacetamide 10% - Sulfur 5% Cleansing cloths is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur. The cleanser base consists of: aloe vera gel, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, glycerol stearate and PEG 100 stearate, green tea extract, magnesium aluminum silicate, methyl paraben, purified water, propyl paraben, sodium cocoyl isethionate, stearyl alcohol, sodium methyl cocoyl taurate, sodium thiosulfate, white petrolatum and xanthan gum.

CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

Uses

INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths are not to be used by patients with kidney disease.

WARNINGS: Although rare, sensitivity to sodium sulfacetaminde may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

PRECAUTIONS: General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desqamation withour irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulfaris, but patients should be cautioned about the possibility.

Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenesis potential.

Pregnancy - Category C - Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths. It is not known whether Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths should be given to a pregnant woman only if clearly needed.

Nursing Mothers - It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths are administered to a nursing woman.

Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

DOSAGE AND ADMINISTRATION: Wash affected area(s) with cleansing cloth once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard cloth. Do not flush.

HOW SUPPLIED: Sodium Sulfacetamide 10% - Sulfur 5% Cleansing Cloths are available in boxes of 30 cloths (3.7 g each), (NDC 42192-138-30) and boxes of 60 cloths (3.7 g each), (NDC 42192-138-60).

Store at controlled room temperature, 20° - 25°C (68° - 77°F).

All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
1-800-541-4802

Rev. 0413

PRINCIPAL DISPLAY PANEL - 3.7 Box

NDC 42192-138-30

Sodium Sulfacetamide 10% -
Sulfur 5% Cleansing Coths

Facial Cleansing Cloths

Rx Only

30 cleansing cloths • Net weight 3.7 g each

Acella
PHARMACEUTICALS, LLC