FINAFTA - alcohol, salicylic acid and 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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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

Uses
Temporary Relief for the Mouth and Gums

Warnings

Flammable: Keep away from fire or flame. Not for prolonged usage.

When using this product: Do not use near eyes.

Stop use and ask a doctor if condition persists or worsen

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "cine" anesthetics. Do not accept if safty seal is broken or missing

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

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

Keep box for Information.
Directions

Use the cap applicator
Apply with the applicator up to four times daily to the affected area of the mouth, gums or mucous membranes.
Do not rinse mouth after use.
Follow any further instructions by doctor to ensure proper and effective recovery.

Other Information:

Close bottle tightly after each use.
Store between 15- 30 degrees Celcius ( 58-86 degrees farhenheit)

Questions or comments?

305-805-3456

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

www.efficientlabs.com

Distributed by
Efficient Laboratories, Inc. Miami Fl 33166 USA

FinaftaLabel

Inactive Ingredients:

Propylene Glycol and Purified Water.

FINAFTA
ethyl alcohol, salicylic acid, benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:58593-780
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (ALCOHOL)	ALCOHOL	60 mL in 100 mL
SALICYLIC ACID (SALICYLIC ACID)	SALICYLIC ACID	1 mg in 100 mL
BENZOCAINE (BENZOCAINE)	BENZOCAINE	5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL
WATER

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58593-780-15	15 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part356	10/01/1991

Labeler - Efficient Laboratories Inc. (969044932)

Revised: 5/2011

Document Id: 780cf5d6-340f-4684-b218-ac030e497713

Set id: 1410fa91-d1bc-4797-b888-9b6971f643e0

Version: 2

Effective Time: 20110511

Efficient Laboratories Inc.