Label: FOOT WORKS HEALTHY ANTIFUNGAL - tolnaftate  powder 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/13

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  • ACTIVE INGREDIENT

    Active ingredient
    Tolnaftate 1.0%.........................

             Purpose
    .......................Antifungal

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  • INDICATIONS & USAGE

    Uses
    • proven clinically effective in the treatment of most athlete’s foot (tinea pedis)
    • relieves itching, burning feet
    • prevents the recurrence of most athlete’s foot (tinea pedis) with daily use

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  • WARNINGS

    Warnings
    For external use only

    Do not use
    • on children under 2 years of age unless directed by a doctor

    When using this product
    • avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if
    • irritation occurs or if there is no improvement within 4 weeks

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions
    • To treat athlete’s foot, clean the affected area with soap and water and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Use daily for 4 weeks. If condition persists longer, consult a doctor. Not effective for infections of the nails or scalp.

    • To prevent athlete’s foot, clean the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
    • Supervise children in the use of this product.
    • Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, cotton socks, and change shoes and socks at least once daily.

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  • INACTIVE INGREDIENT

    Inactive ingredients
    TALC, ZINC OXIDE, SODIUM SILICOALUMINATE, TRICALCIUM PHOSPHATE, METHYLPARABEN, SODIUM POLYACRYLATE, WATER/EAU.

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  • QUESTIONS

    QUESTIONS? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada

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  • INGREDIENTS AND APPEARANCE
    FOOT WORKS HEALTHY  ANTIFUNGAL
    tolnaftate powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10096-0303
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOLNAFTATE (TOLNAFTATE ) TOLNAFTATE 10 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10096-0303-1 74 g in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 04/24/2013
    Labeler - Avon Products, Inc. (001468693)
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