BENZO-JEL  RASPBERRY- 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 USP, in a water soluble base of PEG 3350 USP, PEG 400 USP, flavor, Sodium Saccharin USP, FD&C Red #28, FD&C Red #40 and FD&C Blue #1.

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

Raspberry Flavor

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

PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label
BENZO-JEL   RASPBERRY
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-3416
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine220 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-3416-0134 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
Labeler - Henry Schein, Inc. (012430880)
Registrant - DSHealthcare (056296981)
Establishment
NameAddressID/FEIBusiness Operations
DENTSPLY Caulk083235549MANUFACTURE

Revised: 8/2010
Document Id: 75566fd9-461f-4f06-bb64-2ef6bca44f74
Set id: 07d8c4da-2c28-4aae-a129-03aae15b2991
Version: 1
Effective Time: 20100827
 
Henry Schein, Inc.