Finafta ETHYL ALCOHOL SALICYLIC ACID BENZOCAINE EFFICIENT LABORATORIES INC. FDA Approved Uses For temporary relief of pain associated with canker sores
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Substance Alcohol
Route
TOPICAL
Applications
PART356
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients: (%) Purpose Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic Salicylic Acid 1% w/v.........................Anesthetic/Analgesic Benzocaine USP 5% w/v...................Anesthetic/Analgesic
Inactive Ingredients
Inactive Ingredients: Propylene Glycol and Purified Water.
Strengths
60 % 1 % 5 %
Treats Conditions
Uses For Temporary Relief Of Pain Associated With Canker Sores

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
3K9958V90M U3RSY48JW5 O414PZ4LPZ
Packaging

FinaftaLabel

Package Descriptions
  • FinaftaLabel

Overview

Uses For temporary relief of pain associated with canker sores

Indications & Usage

Uses For temporary relief of pain associated with canker sores

Dosage & 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.

Warnings & 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.
Purpose

Purpose Anesthetic/Analgesic

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.

Questions

Questions or comments? 305-805-3456 Monday-Friday (9 a.m. - 5 p.m. EST) www.efficientlabs.com


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