Ethyl Alcohol, Salicylic Acid, Benzocaine

FDA Drug Profile — Finafta

Drug Details

Generic Name
Ethyl Alcohol, Salicylic Acid, Benzocaine
Brand Names
Finafta
Application Number
part356
Sponsor
Efficient Laboratories Inc.
NDC Codes
1
Dosage Forms
LIQUID
Routes
TOPICAL
Active Ingredients
ALCOHOL, BENZOCAINE, SALICYLIC ACID

Indications and Usage

Uses For temporary relief of pain associated with canker sores

Warnings

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.