Label: TOLNAFTATE cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 4, 2009

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  • 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.

    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.

    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)
  • 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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015-4616

    100% Satisfaction Guaranteed
    www.walgreens.com

    Made in Canada.

  • PRINCIPAL DISPLAY PANEL - 30 g Label

    Walgreens

    NDC 03630-020-02

    TOLNAFTATE Antifungal Cream

    Tolnaftate Cream, 1%
    NET WT 1 OZ (30 g)

    Principal Display Panel - 30 g Label
  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61360-2020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate1 g  in 100 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:61360-2020-21 in 1 CARTON
    130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33308/20/2009
    Labeler - Taro Pharmaceuticals, Inc. (206263295)
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