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 11/13

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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

    Tolnaftate 1% Topical Solution

    Antifungal

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

    NET 1/3 FL OZ (10 mL)

    Perrigo Antifungal
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  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    tolnaftate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45802-701
    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 GLYCOLS  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45802-701-11 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 08/17/2011
    Labeler - Perrigo New York Inc (078846912)
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