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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-0731
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorBANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0731-0134 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/196301/22/2015
Labeler - Henry Schein, Inc. (012430880)

Revised: 4/2015
Document Id: b21e0bb2-e1ae-4a5e-83b0-4db31468d6ff
Set id: 29d5ada3-cacf-4290-b37f-e565f0d9c225
Version: 2
Effective Time: 20150430
 
Henry Schein, Inc.