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Anbesol® Maximum Strength


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient

Benzocaine 20%


Purpose

Oral pain reliever


Uses

  • temporarily relieves pain associated with the following mouth and gum irritations:toothachesore gumscanker soresbracesminor dental proceduresdentures

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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/dentistchildren between 2 and 12 years of age:should be supervised in the use of this productchildren under 2 years of agedo not use
  • for denture irritation:apply thin layer to the affected areado not reinsert dental work until irritation/pain is relievedrinse 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


SPL UNCLASSIFIED SECTION

Distributed by: Foundation Consumer Brands, LLCPittsburgh, PA 15212