Benzo-Jel Banana

benzocaine

Dosage Form: gel, dentifrice
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)

BENZO-JEL   BANANA benzocaine  gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0404-0731 Route of Administration DENTAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor BANANA Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0404-0731-01 34 g In 1 BOTTLE None

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	Operations
DENTSPLY Caulk		083235549	MANUFACTURE

Revised: 07/2010Henry Schein, Inc.

More Benzo-Jel Banana resources

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