Otc - Active Ingredient
Benzocaine 20% . . . Oral pain reliever
Menthol 0.1% . . . Oral pain reliever
Zinc chloride 0.15% . . . Oral astringent
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product 3x Medicated Mouth Sore Gel (NDC 69842-660). 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 otc - active ingredient, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Benzocaine 20% . . . Oral pain reliever
Menthol 0.1% . . . Oral pain reliever
Zinc chloride 0.15% . . . Oral astringent
temporarily relives pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a 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 * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age
Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
cut open tip of tube on score mark * do not use if tip is cut prior to opening * adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age shoul dbe supervised in the use of this product * children under 2 years of age: do not use
allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water
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