ONE TOUCH ADVANCED TOPICAL ANESTHETIC description, usages, side effects, indications, overdosage, supplying and lots more!

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ONE TOUCH ADVANCED TOPICAL ANESTHETIC

HAGER WORLDWIDE, INC.
HAGER WORLDWIDE, INC.




FULL PRESCRIBING INFORMATION

OneTouch
Advanced

Topical Anesthetic Gel                                                                                                                                                                           Rx

Active Ingredients:
Benzocaine
14.0%
Butamben
2.0%
Tetracaine Hydrochloride
2.0%
Inactive Ingredients:
Benzalkonium chloride
0.5%
Cetyl Dimethyl Ethyl Ammonium Bromide
0.005%
In bland, water-soluble base.

Action










Uses

Indications
OneTouch Advanced Gel is a topical anesthetic indicated for the production
of anesthesia of all accessible mucous membrane except the eyes. OneTouch
Advanced Gel is indicated for use to control pain in the mouth.

Dosage and Administration
Only a limited quantity is OneTouch Advanced Gel is required for anesthesia.

Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently
depressing the pump.  Dispensing a bead of gel in excess of 400 mg is contrain-­
dicated. Spread thinly and evenly over the desired area using a cotton swab.

An appropriate pediatric dosage has not been established for OneTouch Ad-­
vanced Gel.

Dosages should be reduced in the debilitated elderly, acutely ill, and very young
patients.

Tissue need not be dried prior to application of OneTouch Advanced Gel. One-
Touch Advanced Gel should be applied directly to the site where pain control is
required. Anesthesia is produced within one minute with an approximate duration
of thirty minutes. Each 200 mg dose of OneTouch Advanced Gel contains 28 mg
of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCI.

Adverse Reactions
Hypersensitivity Reactions:












Precaution: On rare occasions, methemoglobinemia has been reported in
connection with the use of benzocaine-containing products. Care should be
used not to exceed the maximum recommended dosage (see Dosage and
Administration). If a patient becomes cyanotic, treat appropriately to counteract
(such as with methylene blue, if medically indicated).

Use in Pregnancy:




Contraindications
OneTouch Advanced Gel is not suitable and should never be used for injection.
Do not use on the eyes. To avoid excessive systemic absorption, OneTouch
Advanced Gel should not be applied to large areas of denuded or inflamed
tissue. OneTouch Advanced Gel should not be administered to patients who are
hypersensitive to any of its ingredients or to patients known to have cholinest-­
erase deficiencies. Tolerance may vary with status of the patient.
 
OneTouch Advanced Gel should not be used under dentures or cotton rolls, as
retention of the active gel ingredients under a denture or cotton roll could pos-­
sibly cause an escharotic effect. Routine precaution for the use of any topical
anesthetic should be observed when using OneTouch Advanced Gel.

How-Supplied
OneTouch Advanced Gel, 32 g jar

Cool Mint
NDC 62565-901-01
Strawberry Ice
NDC 62565-902-01
Bubble Gum
NDC 62565-903-01
Cherry
NDC 62565-904-01

HAGER
WORLDWIDE





Caution: Rx Only.
Do not use in eyes.  Keep out of reach of children.

Directions: Read package insert.
Press top of container to dispense desired amount.
Dispense 200 mg of gel (a bead approximately
1/4 to 1/2 inches long) by gently depressing the
pump.  Dispensing a bead in excess of 400 mg is
contraindicated.  Spread thinly and evenly over the
desired area using a cotton swab.

Active Ingredients: Benzocaine 14.0%,
Butamben 2.0%, Tetracaine Hydrochloride 2.0%
Inactive Ingredients: Benzalkonium Chloride
0.5%, Cetyl Dimethyl Ethyl Ammonium Bromide
0.005%, in a bland water-soluble base.
NDC 62565-903-01
OneTouch
Advanced


Topical Anesthetic Gel

OneTouch Advanced
is indicated for anesthesia of
accessible mucous membrane.


Bubble Gum
Net Wt. 32 g


Store in a cool dry place.





Manufactured for:
HAGER
WORLDWIDE
Odessa, FL  33556 USA


Item #6256590301



Made in U.S.A.   Rev. 05/09
ONE TOUCH ADVANCED TOPICAL ANESTHETIC

ONE TOUCH ADVANCED TOPICAL ANESTHETIC

BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE GEL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62565-903
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 28 mg
BUTAMBEN Butamben 4 mg
Tetracaine Hydrochloride TETRACAINE 4 mg

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride

Product Characteristics

Color
purple (PURPLE)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 JAR
2 NDC:62565-903-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-02-01


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