BENZO-JEL - benzocaine gel 
Henry Schein, Inc.

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.

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Benzo-Jel™ Unit Dose

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

Mint

Strawberry

Bubble Gum
BENZO-JEL  
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-0742
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Sucralose (UNII: 96K6UQ3ZD4)  
Fd&c Red No. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0742-01100 in 1 CARTON07/03/2015
1.56 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/03/2015
BENZO-JEL  
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-0743
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Sucralose (UNII: 96K6UQ3ZD4)  
D&c Red No. 28 (UNII: 767IP0Y5NH)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0743-01100 in 1 CARTON07/03/2015
1.56 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/03/2015
BENZO-JEL  
benzocaine gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-0741
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
Sucralose (UNII: 96K6UQ3ZD4)  
D&c Red No. 28 (UNII: 767IP0Y5NH)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0741-01100 in 1 CARTON07/03/2015
1.56 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/03/2015
Labeler - Henry Schein, Inc. (012430880)
Registrant - Henry Schein, Inc. (012430880)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories, Inc.002290302manufacture(0404-0741, 0404-0742, 0404-0743)

Revised: 10/2018
Document Id: e70c2284-e953-42d9-a3bc-71a32071252d
Set id: e735d183-609e-53d6-6640-293356e0a8f0
Version: 5
Effective Time: 20181031
 
Henry Schein, Inc.