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Finafta

Medically reviewed by Drugs.com. Last updated on Feb 15, 2020.

Dosage form: liquid
Ingredients: ALCOHOL 60mL in 100mL, SALICYLIC ACID 1mg in 100mL, BENZOCAINE 5mg in 100mL
Labeler: Efficient Laboratories Inc.
NDC Code: 58593-780

Drug Facts

Active Ingredients: (%)              Purpose

Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic

Salicylic Acid 1% w/v.........................Anesthetic/Analgesic

Benzocaine USP 5% w/v...................Anesthetic/Analgesic

Purpose

Anesthetic/Analgesic

Uses

For temporary relief of pain associated with canker sores

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.

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

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. 

Questions or comments?

305-805-3456

Monday-Friday (9 a.m. - 5 p.m. EST)

www.efficientlabs.com

Inactive Ingredients:

Propylene Glycol and Purified Water.

FINAFTA 
ethyl alcohol, salicylic acid, benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-780
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL60 mL  in 100 mL
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID1 mg  in 100 mL
BENZOCAINE (BENZOCAINE) BENZOCAINE5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:58593-780-1515 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/01/1991
Labeler - Efficient Laboratories Inc. (969044932)

 
Efficient Laboratories Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.