Label: ANTIFUNGAL MEDICATED BODY WASH- tolnaftate gel

  • NDC Code(s): 83004-012-01, 83004-012-02, 83004-012-03, 83004-012-04
  • Packager: Rida LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 5, 2024

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  • Active ingredient

    Tolnaftate 1.0%

  • Purpose

    Antifungal

  • Uses

    For treatment of most

    • jock itch
    • ringworm
    • atheletes foot
    • tinea versicolor

    Relieves

    • itching
    • scaling
    • burning
    • redness
    • cracking
    • associated discomfort
  • WARNINGS

    Warning

    For external use only.

    When using this product
    When using this product avoid contact with the eye

    Stop use and ask a doctor ifirritation occurs or if there is no
    improvement within 2 weeks for jock itch or within 4 weeks for athlete's
    foot and ringworm.

    Do not use
    Do Not use on children under 2 under 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.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Make sure to dry affected area thoroughly.
    • Supervise children in the use of this product.
    • For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
    • Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
    • This product is not effective on the scalp or nails.
  • Inactive ingredients

    TETRASODIUM GLUTAMATE DIACETATE, EUCALYPTUS OIL, WATER, SODIUM GLUCONATE, SODIUM PALM KERNELATE, GLYCERIN, MELALEUCA ALTERNIFOLIA LEAF, SODIUM CHLORIDE, ACTIVATED CHARCOAL, SODIUM COCOATE, SODIUM PALMATE, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM COCOATE

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL MEDICATED BODY WASH 
    tolnaftate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83004-012
    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
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83004-012-0156 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/06/2024
    2NDC:83004-012-02113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/06/2024
    3NDC:83004-012-03226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/06/2024
    4NDC:83004-012-04453 g in 1 PACKAGE; Type 0: Not a Combination Product06/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/06/2024
    Labeler - Rida LLC (004425803)