Anbesol Gel
FDA Label NDC 80070-220

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Foundation Consumer Brands for the product Anbesol (NDC 80070-220). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, methemoglobinemia warning, allergy alert, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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

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

Otc - Keep Out Of Reach Of Children

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 overapply 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 ageadult supervision should be given in the use of this product
    children under 2 years of agedo 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 1-888-594-0673 weekdays 9 AM to 5 PM EST

Principal Display Panel - 9 G Tube Blister Pack

gel

Anbesol®
Oral Pain Reliever/Benzocaine 20%

MAXIMUM
STRENGTH

Instant
Pain Relief

  • ✓Toothaches
  • ✓Gum Pain
  • ✓Canker Sores
  • ✓Denture Pain

    • NET WT 0.33 OZ (9 g)

    Principal Display Panel (9 g Tube Blister Pack)

    Principal Display Panel (9 g Tube Blister Pack)

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