Finafta
1410fa91-d1bc-4797-b888-9b6971f643e0
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredients: (%) Purpose Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic Salicylic Acid 1% w/v.........................Anesthetic/Analgesic Benzocaine USP 5% w/v...................Anesthetic/Analgesic
Medication Information
Warnings and Precautions
Warnings
Methemoglobinemia warning: Use of this product may cause mthemoglobinemia, a serious condition that must be treated promptyly because it reduces the amount of oxygen carried in the 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 enegry
Allegry alert
- do not use this product if you have a history of allergy to local anesthetics such as prcaine, butacaine, bezocaine, or other "caine" anesthetics.
Alcogol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whehter you should take slicylic acid or other pain reliever, fever reducer. Salicylic acid may cause stomach bleeding.
Flammable: Keep away from fire or flame.
Do not use
- for teething
- in children under 2 years of age
When using this prduct Do not use near eyes. Do not prolong usage unless directed by a doctor/dentist.
Stop use and ask a doctor promptly if sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persists or worsens. If you sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.
Indications and Usage
Uses
For temporary relief of pain associated with canker sores
Dosage and Administration
Directions
Adults and children over 12 years of age apply to the affected area, mouth, gums or mucous membrane with the applicator provided, up to 4 times daily or as directed by a dentist or doctor. Remain in place at least 1 minute and then spit out. Do not rinse mouth after each use. Children under 12 years of age should be supervised in the use of the product. Do not use in children under 2 years of age.
Description
Active Ingredients: (%) Purpose Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic Salicylic Acid 1% w/v.........................Anesthetic/Analgesic Benzocaine USP 5% w/v...................Anesthetic/Analgesic
Section 50565-1
Keep out of reach of children. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.
Section 51727-6
Inactive Ingredients:
Propylene Glycol and Purified Water.
Section 51945-4
Section 53413-1
Questions or comments?
305-805-3456
Monday-Friday (9 a.m. - 5 p.m. EST)
www.efficientlabs.com
Section 55105-1
Purpose
Anesthetic/Analgesic
Section 55106-9
Active Ingredients: (%) Purpose
Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic
Salicylic Acid 1% w/v.........................Anesthetic/Analgesic
Benzocaine USP 5% w/v...................Anesthetic/Analgesic
Structured Label Content
Indications and Usage (34067-9)
Uses
For temporary relief of pain associated with canker sores
Dosage and Administration (34068-7)
Directions
Adults and children over 12 years of age apply to the affected area, mouth, gums or mucous membrane with the applicator provided, up to 4 times daily or as directed by a dentist or doctor. Remain in place at least 1 minute and then spit out. Do not rinse mouth after each use. Children under 12 years of age should be supervised in the use of the product. Do not use in children under 2 years of age.
Warnings and Precautions (34071-1)
Warnings
Methemoglobinemia warning: Use of this product may cause mthemoglobinemia, a serious condition that must be treated promptyly because it reduces the amount of oxygen carried in the 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 enegry
Allegry alert
- do not use this product if you have a history of allergy to local anesthetics such as prcaine, butacaine, bezocaine, or other "caine" anesthetics.
Alcogol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whehter you should take slicylic acid or other pain reliever, fever reducer. Salicylic acid may cause stomach bleeding.
Flammable: Keep away from fire or flame.
Do not use
- for teething
- in children under 2 years of age
When using this prduct Do not use near eyes. Do not prolong usage unless directed by a doctor/dentist.
Stop use and ask a doctor promptly if sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persists or worsens. If you sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.
Section 50565-1 (50565-1)
Keep out of reach of children. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.
Section 51727-6 (51727-6)
Inactive Ingredients:
Propylene Glycol and Purified Water.
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments?
305-805-3456
Monday-Friday (9 a.m. - 5 p.m. EST)
www.efficientlabs.com
Section 55105-1 (55105-1)
Purpose
Anesthetic/Analgesic
Section 55106-9 (55106-9)
Active Ingredients: (%) Purpose
Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic
Salicylic Acid 1% w/v.........................Anesthetic/Analgesic
Benzocaine USP 5% w/v...................Anesthetic/Analgesic
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:01:06.920802 · Updated: 2026-03-14T23:01:15.754566