Label: BENZO-JEL- benzocaine gel
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Contains inactivated NDC Code(s)
NDC Code(s): 0404-0741-01, 0404-0742-01, 0404-0743-01 - Packager: Henry Schein, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated October 31, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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.
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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)
- Package Label
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INGREDIENTS AND APPEARANCE
BENZO-JEL
benzocaine gelProduct 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 gelProduct 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 gelProduct 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)
