5820619 Triple Medicated Mouth Sore Gel (8015600)
a71c5259-cbd1-7566-e053-2995a90a2cb6
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients Purpose Benzocaine 20% . . . . . .Oral pain reliever Menthol 0.1% . . . . . . . . Oral pain reliever Zinc chloride 0.15% . . . .Oral astringent
Medication Information
Warnings and Precautions
Methemoglobinemia warning: use of this product may cause methoglobinemia, 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
Indications and Usage
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 between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
- children under 2 years of age: do not use
Dosage and Administration
- 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 between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
- children under 2 years of age: do not use
Description
Active ingredients Purpose Benzocaine 20% . . . . . .Oral pain reliever Menthol 0.1% . . . . . . . . Oral pain reliever Zinc chloride 0.15% . . . .Oral astringent
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and ask a doctor if
- sore mouth symptoms do not improve in 7 days
- swelling, rash or fever develops
- irritaiton, pain or redness persists or worsens
Section 51727-6
allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water
Section 51945-4
Section 53413-1
Questions and Comments? Call 1-877-7777-2743
Section 55105-1
for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums
Section 55106-9
Active ingredients Purpose
Benzocaine 20% . . . . . .Oral pain reliever
Menthol 0.1% . . . . . . . . Oral pain reliever
Zinc chloride 0.15% . . . .Oral astringent
Section 60561-8
Do not use
- more than directed
- for more than 7 days unless directed by a dentist or doctor
- for teething
- in children under 2 years of age
Allergy Alert
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
Structured Label Content
Indications and Usage (34067-9)
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 between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
- children under 2 years of age: do not use
Dosage and Administration (34068-7)
- 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 between 2 and 12 years of age: ask a doctor before use. Should be supervised in the use of this product
- children under 2 years of age: do not use
Warnings and Precautions (34071-1)
Methemoglobinemia warning: use of this product may cause methoglobinemia, 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
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
- sore mouth symptoms do not improve in 7 days
- swelling, rash or fever develops
- irritaiton, pain or redness persists or worsens
Section 51727-6 (51727-6)
allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions and Comments? Call 1-877-7777-2743
Section 55105-1 (55105-1)
for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums
Section 55106-9 (55106-9)
Active ingredients Purpose
Benzocaine 20% . . . . . .Oral pain reliever
Menthol 0.1% . . . . . . . . Oral pain reliever
Zinc chloride 0.15% . . . .Oral astringent
Section 60561-8 (60561-8)
Do not use
- more than directed
- for more than 7 days unless directed by a dentist or doctor
- for teething
- in children under 2 years of age
Allergy Alert (Allergy alert)
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
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:43.308098 · Updated: 2026-03-14T23:09:39.646164