BENZO-JEL BUBBLE GUM- benzocaine gel

Benzo-Jel by

Drug Labeling and Warnings

Benzo-Jel by is a Prescription medication manufactured, distributed, or labeled by Henry Schein Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, and FD&C Red #28.

USUAL DOSAGE

For oral mucosal use only as directed by a dentist.

WARNING

Keep out of the reach of children.

STORAGE AND HANDLING

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.

SPL UNCLASSIFIED SECTION

Reorder #101-9442

1731025LA (R 5/19/10)

NDC# 0404-9442-01

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

Bubble Gum

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

INGREDIENTS AND APPEARANCE

BENZO-JEL   BUBBLE GUM
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-9442
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	230 mg  in 1 mL

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-9442-01	29.6 mL in 1 JAR; Type 0: Not a Combination Product

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)