Label: ATHLETES FOOT- tolnaftate cream

  • 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

    proven clinically effective in the treatment of most
    athlete’s foot (tinea pedis)
    ringworm (tinea corporis)
    helps prevent most athlete’s foot with daily use
    for effective relief of
    itching
    burning
    cracking
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  • Warnings

    For external use only

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    irritation occurs
    there is no improvement within 4 weeks

    Do not use

    on children under 2 years of age unless directed by a doctor

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    wash affected area and dry thoroughly
    apply a thin layer over affected area twice daily (morning and night)
    supervise children in the use of this product
    for athlete’s foot: pay special attention to spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    use daily for 4 weeks. If condition lasts longer, ask a doctor.
    to prevent athlete’s foot, apply once or twice daily (morning and/or night)
    this product is not effective on the scalp or nails
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  • Other information

    store at 68°-77°F (20°-25°C)

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  • Inactive ingredients

    butylated hydroxytoluene, carbomer homopolymer, monoamylamine, PEG-400, propylene glycol, titanium dioxide

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  • Questions or comments?

    1-800-632-6900

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  • Principal Display Panel

    COMPARE TO the active ingredient of TINACTIN® ANTIFUNGAL CREAM

    See bottom panel

    Athlete’s Foot Cream

    Tolnaftate 1%

    ANTIFUNGAL CREAM

    Cures & Prevents Most Athlete’s Foot

    Effective Relief of Itching & Burning

    Greaseless, Odorless

    NET WT 0.5 OZ (14 g)

    Kroger Co. Athlete's Foot Cream
    Kroger Co. Athlete's Foot Cream
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  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    tolnaftate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-533
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE  
    POLYETHYLENE GLYCOL 400  
    PROPYLENE GLYCOL  
    TITANIUM DIOXIDE  
    PENTYLAMINE  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-533-58 1 in 1 CARTON
    1 14 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 01/26/2012
    Labeler - Kroger Company (006999528)
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