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Finafta

Efficient Laboratories Inc.

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Anesthetic/Analgesic

Uses

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

Finafta

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

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ALCOHOL ALCOHOL 60 mL
Salicylic Acid SALICYLIC ACID 1 mg
BENZOCAINE Benzocaine 5 mg

Inactive Ingredients

Ingredient Name Strength
propylene glycol
water

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 1991-10-01


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Be sure to consult your doctor before taking any medication!
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