Label: TOLNAFTATE cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate USP 1%

  • Purpose

    Antifungal

  • Uses

    • for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • for effective relief of itchy, scaly skin between the toes
    • clears up most athlete's foot infection and with daily use helps keep it from coming back
  • 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 eyes

    Stop use and ask a doctor if

    • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
    • irritation occurs or if there is no improvement within 2 weeks (for jock itch)

    Keep this and all drugs out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

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

    For athlete's foot

    • use daily for 4 weeks. If condition persists longer, consult a doctor
    • pay special attention to the spaces between the toes
    • wear well fitting ventilated shoes
    • change shoes and socks at least once daily

    For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

    For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

    This product is not effective on the scalp or nails.

  • Other information

    • Store at controlled room temperature 15°-30°C (59°-86°F)
    • Lot No. and Exp date: see crimp on tube or see box
  • Inactive ingredients

    Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Phosphate Monobasic, White Petrolatum

  • Questions?

    Adverse Drug Event call (800)616-2471

    Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

    Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

  • Principal Display Panel –

    pdp

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4245(NDC:0904-0722)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4245-514.18 g in 1 TUBE; Type 0: Not a Combination Product01/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01402/11/2010
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-4245)
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