OTC Medication Information: 3x Medicated Mouth Sore Gel
3X MEDICATED MOUTH SORE GEL- benzocaine, menthol, unspecified form and zinc chloride gel
CVS
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Benzocaine 20% . . . Oral pain reliever
Menthol 0.1% . . . Oral pain reliever
Zinc chloride 0.15% . . . Oral astringent
Uses
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.
Directions
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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Labeler — CVS (062312574) |
Registrant — Lornamead (080046418) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Lornamead | 080046418 | manufacture (69842-660) |
Revised: 01/2023 CVS
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https://otclabels.com/lib/otc/otc-meds/3x-medicated-mouth-sore-gel-2/