Finafta

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

UsesTemporary relief of pain associated with the following mouth and gum conditions:

  • Canker sores
  • Minor irritation and sore
  • Irritation and pain due to minor dental procedures

Warnings

Alcohol warning:If you consumer 3 or more alcohol drink everyday, ask your doctor whether you should take salicylic acid or other pain reliever, fever reducer. Solicylic acid may cause stomach bleeding. Do not exceed recommended dosage. Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine anesthetics". For children less than 12 years of age, consult a physician.

Flammable: Keep away from fire or flame.

When using this product: Do not use near eyes. Do not prolong usage unless directed by a doctor/dentist.

Stop use and ask a doctor if: Sore mouth symptoms do not improve in 7 days: if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops.

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

If pregnant or nursing a baby, contact your doctor before using.

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. Close bottle tightly after each use.

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)

Revised: 01/2014
 
Efficient Laboratories Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)