Label: MEIJER ANTIFUNGAL- tolnaftate cream

  • NDC Code(s): 41250-499-01
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • 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
  • 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
    • there is no improvement within 4 weeks

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

  • 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
  • Other information

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

    butylated hydroxytoluene, polyethylene glycol 400, polyethylene glycol 3350, titanium dioxide, white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DIST. BY MEIJER
    DISTRIBUTION, INC.GRAND RAPIDS,
    MI 49544
    www.meijer.com
    Made in Canada

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    carton-01meijer™

    Cures & Prevents Most Athlete's Foot

    AntifungalCream
    Tolnaftate 1% Cream

    NET WT 0.5 OZ (15 g)

  • INGREDIENTS AND APPEARANCE
    MEIJER   ANTIFUNGAL
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-499
    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)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-499-011 in 1 CARTON02/17/2006
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/17/2006
    Labeler - Meijer Distribution Inc (006959555)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(41250-499)
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