Label: EQUATE  ATHLETES FOOT- tolnaftate cream 

  • 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 02/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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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) and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use
    • for effective relief of itching, burning and cracking
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  • Warnings

    For external use only

    When using this product avoid contact with 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 except under the advice and supervision of a doctor.

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

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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 persists 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 between 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
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  • Inactive ingredients

    BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

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  • Questions?

    Call 1-888-287-1915

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716.

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  • PRINCIPAL DISPLAY PANEL- 30 g Tube Carton

    NDC 49035-499-03

    equate

    Compare
    to Tinactin®
    Active
    Ingredient*

    Athlete's
    Foot

    Tolnaftate Cream 1%
    Antifungal

    Cures and Prevents
    Most Athlete's Foot

    • Relieves burning & itching

    NET WT 1 OZ (30 g)

    Principal Display Panel - 30 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    EQUATE   ATHLETES FOOT
    tolnaftate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-499
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Tolnaftate (Tolnaftate) Tolnaftate 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Butylated Hydroxytoluene  
    Polyethylene glycol 400  
    titanium dioxide  
    petrolatum  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-499-03 1 in 1 CARTON
    1 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 02/17/2006
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49035-499)
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