BENZO-JEL  PINA COLADA- benzocaine gel 
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.

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.

Reorder #101-3099

1731024LA (R 5/19/10)

NDC# 0404-3099-01

Distributed By:
HENRY SCHEIN INC.
Melville, NY 11747 Made in USA

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label

HENRY SCHEIN®

BENZO-JEL™
TOPICAL ANESTHETIC GEL

Piña Colada Flavor

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

PRINCIPAL DISPLAY PANEL - 29.6 mL Jar Label
BENZO-JEL   PINA COLADA
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-3099
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine230 mg  in 1 mL
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCOCONUT (Pina Colada) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-3099-0129.6 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/19/1963
Labeler - Henry Schein Inc (012430880)

Revised: 5/2015
Document Id: 5c35bbaf-1e02-4f90-9a38-1d78b15feb3a
Set id: 822a8663-0db8-469c-97ed-3977ab9d5933
Version: 1
Effective Time: 20150501
 
Henry Schein Inc