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FDA LABEL GENERIC: Benzocaine MFR: Foundation Consumer Brands

Anbesol 0.2 Mg/mg Oral Gel

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Uses

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

Warnings

METHEMOGLOBINEMIA WARNING

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy

Allergy alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

Do not use

for teething in children under 2 years of age

When using this product

avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days irritation, pain, or redness lasts or worsens swelling, rash, or fever develops

Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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 information

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

Inactive ingredients

benzyl alcohol, carbomer 934P, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, methylparaben, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin

Questions or comments?

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

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

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)