Label: TOLNAFTATE ANTIFUNGAL- tolnaftate cream

  • Category: HUMAN OTC DRUG LABEL

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Updated June 23, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use
    • for effective relief of
      • itching
      • scaling
      • cracking
      • burning
      • redness
      • soreness
      • irritation
      • discomfort
  • Warnings

    For external use only

    Ask a doctor before use

    • on children under 2 years of age

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

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

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

  • Directions

    This product is not effective on the scalp or nails.

    For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over 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

    pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily

  • Other information

    • store at room temperature
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

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

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed By
    AmerisourceBergen
    1300 Morris Drive
    Chesterbrook, PA 19087

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    GOOD
    NEIGHBOR
    PHARMACY®

    Compare to the Tinactin® active ingredient*

    NDC 24385-032-03

    Tolnaftate 1% Cream
    Antifungal Cream

    Cures & Prevents Most Athlete's Foot

    NET WT 1 oz (30 g)

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE  ANTIFUNGAL
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-032
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-032-031 in 1 CARTON02/17/2006
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C02/17/2006
    Labeler - Amerisource Bergen (007914906)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(24385-032)
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