5820619 Triple Medicated Mouth Sore Gel (8015600)

5820619 Triple Medicated Mouth Sore Gel (8015600)
SPL v5
SPL
SPL Set ID a71c5259-cbd1-7566-e053-2995a90a2cb6
Route
ORAL
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (0.1 g) Benzocaine (20 g) Zinc Cation (0.15 g)
Inactive Ingredients
Polysorbate 60 Polyethylene Glycol 400 Propylene Glycol Saccharin Methyl Salicylate Povidone K90 Stearyl Alcohol Water Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Sorbic Acid Allantoin Edetic Acid

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-02

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


Advanced Ingredient Data


Raw Label Data

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