Anbesol

Manufacturer
Foundation Consumer Brands
Effective date
2026-06-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-07-17 21:35:05

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Uses

Uses

temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures

Warnings

Warnings

Directions And Dosage

Directions

to open tube, cut tip of the tube on score mark with scissors adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age adult supervision should be given in the use of this product children under 2 years of age do not use for denture irritation: apply thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting

Other Label Information

Other information

store at 20-25°C (68-77°F) do not refrigerate

Inactive ingredients

benzyl alcohol, carbomer homopolymer type b, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin

Questions or comments?

Call 1-888-594-0673 weekdays 9 AM to 5 PM EST

PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack

MAXIMUM STRENGTH 20% Benzocaine Anbesol ® Oral Pain Reliever/Benzocaine 20% Instant Oral Pain Relief ADA Accepted American Dental Association Toothaches Canker Sores Aligner Pain Gum Pain GEL NET WT 0.33 OZ (9 g)

Label Images#

anbesol gel
anbesol gel

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80070-22080070-220-33

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

to open tube, cut tip of the tube on score mark with scissors adults and children 2 years of age and over apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist children under 12 years of age adult supervision should be given in the use of this product children under 2 years of age do not use for denture irritation: apply thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting

Other information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F) do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer homopolymer type b, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-594-0673 weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Distributed by: Foundation Consumer Brands, LLC Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 9 g Tube Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH 20% Benzocaine Anbesol ® Oral Pain Reliever/Benzocaine 20% Instant Oral Pain Relief ADA Accepted American Dental Association Toothaches Canker Sores Aligner Pain Gum Pain GEL NET WT 0.33 OZ (9 g)

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-02-19full-release2026-06-01 00:55:37