The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Distributed by: Foundation Consumer Brands, LLCPittsburgh, PA 15212
Oral pain reliever
- Temporarily relieves pain associated with the following mouth and gum irritations:toothachesore gumscanker soresbracesminor dental proceduresdentures
- 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)headacherapid heart rateshortness of breathdizziness or lightheadednessfatigue or lack of energy
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 teethingin children under 2 years of age
When Using This Product
- Avoid contact with the eyesdo not exceed recommended dosagedo 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 daysirritation, pain, or redness lasts or worsensswelling, 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.
- 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 under 12 years of ageadult supervision should be given in the use of this productchildren under 2 years of agedo not usefor denture irritation:apply thin layer to the affected areado not reinsert dental work until irritation/pain is relievedrinse mouth well before reinserting
- Store at 20-25°C (68-77°F)do not refrigerate
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
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