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Name:Benzo-jel Banana
Manufacturer:Henry Schein, Inc.
Category:Prescription Marketed Drugs


BENZO-JEL™

BENZO-JEL  BANANA - benzocaine gel, dentifrice 
Henry Schein, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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BENZO-JEL™

INGREDIENTS

Each gram of Benzo-Jel™ 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 USP, PEG 400 USP, flavor, Sodium Saccharin USP, and FD&C Yellow #5, and FD&C Red #40.

CAUTION: Contains FD&C Yellow #5 (tartrazine) which may cause an allergic response.

USUAL DOSAGE

For oral mucosal use only as directed by a dentist.

WARNING

Keep out of the reach of children.

Store at controlled room temperature 59°-86°F (15°-30°C).

Do not use on people with known allergies to benzocaine and PABA compounds.

CAUTION

Federal law (USA) prohibits dispensing without prescription.

Distributed By:
HENRY SCHEIN INC.
Melville, NY 11747

PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label

HENRY SCHEIN®

BENZO-JEL™
TOPICAL ANESTHETIC GEL

Banana Flavor

20% Benzocaine
FOR PROFESSIONAL USE ONLY
1 FL. OZ. (29.6 mL)

PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label

BENZO-JEL   BANANA
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-0731
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 220 mg  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor BANANA Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-0731-01 34 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/19/1963

Labeler - Henry Schein, Inc. (012430880)
Registrant - DSHealthcare (056296981)
Establishment
Name Address ID/FEI Operations
DENTSPLY Caulk 083235549 MANUFACTURE

Revised: 07/2010 Henry Schein, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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