BENZO-JEL- benzocaine gel, dentifrice

Benzo-Jel by

Drug Labeling and Warnings

Benzo-Jel by is a Prescription medication manufactured, distributed, or labeled by Henry Schein, Inc., DSHealthcare, DENTSPLY Caulk. 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, 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.

STORAGE AND HANDLING

Store at controlled room temperature 59°-86°F (15°-30°C).

SPL UNCLASSIFIED SECTION

Do not use on people with known allergies to benzocaine and PABA compounds.

CAUTION

Federal law (USA) prohibits dispensing without prescription.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

BENZO-JEL   RASPBERRY
benzocaine gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-3416
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	220 mg  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-3416-01	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	Business Operations
DENTSPLY Caulk		083235549	MANUFACTURE