Benzo-Jel: Package Insert / Prescribing Information - Drugs.com

Skip to main content
Print
Save

# Benzo-Jel

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

Medically reviewed by Drugs.com. Last updated on Sep 21, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

## 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)

Registrant - Henry Schein, Inc. (012430880)

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

Henry Schein, Inc.

## More about Benzo-Jel (benzocaine topical)

- Check interactions
- Latest FDA alerts (5)
- Side effects
- Dosage information
- During pregnancy
- Drug class: topical anesthetics
- Breastfeeding

### Professional resources

- Prescribing Information
- Benzocaine Gel (FDA)

#### Other brands

Precaine B, Topical Anesthetic Dental Gel, Topex, Orajel Baby, ... +2 more

### Related treatment guides

- Pain
- Aphthous Ulcer
- Oral and Dental Conditions

Medical Disclaimer