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Benzo-Jel Prescribing Information

Package insert / product label
Generic name: benzocaine
Dosage form: gel, dentifrice
Drug class: Topical anesthetics

Medically reviewed by Drugs.com. Last updated on Mar 11, 2022.

Benzo-Jel Dosage and Administration

Warnings

Storage and Handling

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.

How is Benzo-Jel supplied


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)