Label: ANTIFUNGAL- tolnaftate solution

  • 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 09/09

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  • Active ingredient

    Tolnaftate 1%

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  • Purpose

    Antifungal

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  • Uses

    • for effective treatment of most:
    • athlete’s foot (tinea pedis)
    • ringworm (tinea corporis)
    • jock itch (tinea cruris)
    • for effective relief of itchy, scaly skin between the toes
    • helps prevent most athlete’s foot from coming back with daily use
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  • 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

    Stop use and ask a doctor if

    • irritation occurs
    • athlete’s foot or ringworm does not improve within 4 weeks
    • jock itch does not improve within 2 weeks

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night)
    • supervise children in the use of this product

    For athlete’s foot

    • use daily for 4 weeks
    • pay special attention to the spaces between the toes
    • wear well-fitting, ventilated shoes
    • change shoes and socks at least once daily
    • to prevent athlete’s foot, clean and dry feet thoroughly. Apply as above once or twice daily.

    For ringworm

    • use daily for 4 weeks. If condition lasts longer, ask a doctor

    For jock itch

    • use daily for 2 weeks. If condition lasts longer, ask a doctor
    • this product is not effective on the scalp or nails
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  • Inactive ingredients

    butylated hydroxytoluene, polyethylene glycol

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Topical Solution

    Antifungal Solution

    Tolnaftate 1%

    For the cure of most athlete’s foot, jock itch & ringworm

    Antifungal Solution Carton

    Antifungal Solution Carton

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  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    tolnaftate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45802-033
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE  
    POLYETHYLENE GLYCOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45802-033-85 1 in 1 CARTON
    1 10 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 12/06/2005
    Labeler - Perrigo New York Inc (078846912)
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