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Benzo-Jel Banana

Generic Name: benzocaine
Dosage Form: gel, dentifrice

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.

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.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

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)

BENZO-JEL   BANANA
benzocaine gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:0404-0731-01 34 g in 1 BOTTLE
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.



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