3x Medicated Mouth Sore Gel
5820600 3x Med Gel
a7572c4f-089b-0e80-e053-2a95a90a0ddf
HUMAN OTC DRUG LABEL
Aug 12, 2025
CVS
DUNS: 062312574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
OTC - ACTIVE INGREDIENT SECTION
Benzocaine 20% . . . Oral pain reliever
Menthol 0.1% . . . Oral pain reliever
Zinc chloride 0.15% . . . Oral astringent
OTC - PURPOSE SECTION
Uses
temporarily relives pain caused by * canker sores * cold sores * fever blisters * minor irritation or injury of the mouth and gums
WARNINGS SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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
INACTIVE INGREDIENT SECTION
allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water