BENZO-JEL- benzocaine gel

Benzo-Jel by

Drug Labeling and Warnings

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

Drug Details [pdf]

Directions for Use:1. Using the pull tab, peel open the lidding material first exposing the cotton tip applicator and then the individual reservoir of Benzo-Jel.2. Using the cotton tip applicator, apply Benzo-Jel to the desired mucosa.

Warnings: Keep out of reach of children. Do not use on people with known allergies to benzocaine.

Storage: Store Benzo-Jel at controlled room temperature, between 59 and 86°F (15 and 30°C).

Caution: Federal law (USA) prohibits dispensing without a prescription.
Ingredients:
Active: Each gram of 20% Benzocaine gel contains 200mg of Benzocaine USP
Inactive:
Strawberry: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavor, FD&C Red # 40
Bubble Gum: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavor, D&C Red # 28
Mint: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavors, D&C Green # 5

For professional use only.

REORDER #’S: Strawberry (#112-7286)Bubble Gum (#112-7287)Mint (#112-7288) NDC # 0404-0742-01 (Strawberry) NDC # 0404-0743-01 (Bubble Gum) NDC # 0404-0741-01 (Mint)     

Distributed by (in US only):
HENRY SCHEIN, INC.
135 DURYEA ROAD
MELVILLE, NY 11747 USA
MADE IN USA
246001      Rev Date: 05/2015

Package Label

INGREDIENTS AND APPEARANCE

BENZO-JEL  
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-0742
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Sucralose (UNII: 96K6UQ3ZD4)
Fd&c Red No. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0742-01	100 in 1 CARTON	07/03/2015
1		.56 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/03/2015

BENZO-JEL  
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-0743
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Sucralose (UNII: 96K6UQ3ZD4)
D&c Red No. 28 (UNII: 767IP0Y5NH)

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: 0404-0743-01	100 in 1 CARTON	07/03/2015
1		.56 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/03/2015

BENZO-JEL  
benzocaine gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-0741
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Sucralose (UNII: 96K6UQ3ZD4)
D&c Red No. 28 (UNII: 767IP0Y5NH)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0741-01	100 in 1 CARTON	07/03/2015
1		.56 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/03/2015

Labeler - Henry Schein, Inc. (012430880)

Registrant - Henry Schein, Inc. (012430880)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc.		002290302	manufacture(0404-0741, 0404-0742, 0404-0743)