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  5. Label Information: Anbesol Maximum Strength

FDA Label for Anbesol Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. METHEMOGLOBINEMIA WARNING
    6. ALLERGY ALERT
    7. DO NOT USE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 12 ML BOTTLE BLISTER PACK

Anbesol Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Foundation Consumer Brands. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



adults and children 2 years of age and overwipe liquid on with cotton, or cotton swab, or fingertip, apply 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)


Inactive Ingredients



benzyl alcohol, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, 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 - 12 Ml Bottle Blister Pack



liquid

Anbesol®
Oral Pain Reliever/Benzocaine 20%

MAXIMUM
STRENGTH

Instant
Pain Relief

* Please review the disclaimer below.