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Benzo-Jel

Generic Name: benzocaine
Dosage Form: gel, dentifrice

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.

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

Benzo-Jel  
benzocaine gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0404-0742
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 200 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Polyethylene Glycol 400  
Polyethylene Glycol 3350  
Sucralose  
Fd&c Red No. 40  
Product Characteristics
Color RED Score     
Shape Size
Flavor STRAWBERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0404-0742-01 100 CUP, UNIT-DOSE in 1 CARTON
1 .56 g in 1 CUP, UNIT-DOSE
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 LABEL Item Code (Source) NDC:0404-0743
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 200 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Polyethylene Glycol 400  
Polyethylene Glycol 3350  
Sucralose  
D&c Red No. 28  
Product Characteristics
Color PINK Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0404-0743-01 100 CUP, UNIT-DOSE in 1 CARTON
1 .56 g in 1 CUP, UNIT-DOSE
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 LABEL Item Code (Source) NDC:0404-0741
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzocaine (Benzocaine) Benzocaine 200 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Polyethylene Glycol 400  
Polyethylene Glycol 3350  
Sucralose  
D&c Red No. 28  
Product Characteristics
Color GREEN Score     
Shape Size
Flavor MINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0404-0741-01 100 CUP, UNIT-DOSE in 1 CARTON
1 .56 g in 1 CUP, UNIT-DOSE
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)
Revised: 06/2015
 
Henry Schein, Inc.



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