FINAFTA- ethyl alcohol, salicylic acid, benzocaine liquid 
Efficient Laboratories Inc.

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.

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Finafta

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:

Allegry alert

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

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.

FinaftaLabel

FINAFTA 
ethyl alcohol, salicylic acid, benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-780
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 100 mL
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58593-780-1515 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/01/1991
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/01/199106/01/2026
Labeler - Efficient Laboratories Inc. (969044932)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58593-780)

Revised: 8/2023
Document Id: 025a45e6-c192-f848-e063-6394a90a1e29
Set id: 1410fa91-d1bc-4797-b888-9b6971f643e0
Version: 10
Effective Time: 20230807
 
Efficient Laboratories Inc.