Label: FOOT WORKS HEALTHY ANTIFUNGAL- tolnaftate spray

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

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.

Drug Label Information

Updated January 1, 2019

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  • ACTIVE INGREDIENT

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

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

  • 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

  • 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.

  • INACTIVE INGREDIENT

    Inactive ingredients
    SD ALCOHOL 40-B, PEG-12, PEG-6, PROPYLENE CARBONATE, PARFUM/FRAGRANCE, BHT.

  • QUESTIONS

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

  • 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.

    Flammable. Keep from fire or heat.

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFB

  • INGREDIENTS AND APPEARANCE
    FOOT WORKS HEALTHY  ANTIFUNGAL
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10096-0272
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10096-0272-1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/19/2011
    Labeler - New Avon LLC (080143520)
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