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Finafta (Efficient Laboratories Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 15 mL in 1 BOTTLE, WITH APPLICATOR (58593-780-15) Label Information

Complete Finafta 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


  • INDICATIONS & USAGE

    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

    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.


  • DO NOT USE

    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

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


  • PREGNANCY OR BREAST FEEDING

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


  • DOSAGE & ADMINISTRATION

    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

    Questions or comments?

    305-805-3456

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

    www.efficientlabs.com


  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Propylene Glycol and Purified Water.


  • INGREDIENTS AND APPEARANCE
    FINAFTA 
    ethyl alcohol, salicylic acid, benzocaine liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-780
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 60 mL  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 mg  in 100 mL
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58593-780-15 15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 10/01/1991
    Labeler - Efficient Laboratories Inc. (969044932)