Label: ATHLETES FOOT- 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 February 21, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Tolnaftate 1.0%

  • Purpose

    Antifungal

  • Uses

    Cures and prevents most Athlete's Foot. Relieves itching and burning.

  • Warnings

    For external use only. Avoid contact with eyes. Stop and ask doctor if irritation occurs or there is no improvement within four weeks.

    Keep out of reach of children. Do not use on children under two years old unless under supervision of a doctor. If swallowed, seek medical help or contact the poison control center.

  • Directions

    Wash affected area and dry thoroughly. Apply a thin layer over affected area twice daily (morning and night). Pay special attention to spaces between the toes, wear well fitting shoes and change shoes and socks at least once daily.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Achillea Millefolium (Yarrow) Extract, Allantoin, Anthemis Nobilis (Chamomile) Extract, Bentonite, Citric Acid, Echinacea Purpurea Extract, Equisetum Arvense (Horsetail) Extract, Glycereth-7 Cocoate, Glycerin, Glycyrrhiza Glabra (Licorice Root) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hibiscus Syriacus (Althaea) Extract, Kaolin, Laminaria Digitata (Sea Kelp) Extract, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Oil, Melissa Officinalis (Balm Mint) Extract, Menthol, Methyl Paraben, Mixed Tocopherols (Vitamin E), Origanum Vulgare (Oregano) Oil, Panthenol, Propyl Paraben, Purified Water, Rosmarinus Officinalis (Rosemary) Extract, Salvia Officinalis (Sage) Extract, Stearic Acid, Thymus Vulgaris (Thyme) Extract, Tussilago Farfara (Coltsfoot) Extract, Zinc Oxide.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: QUANTUM, INC.
    PO BOX 2791, EUGENE, OR 97402

  • PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

    Quantum®
    HEALTH

    Athlete's
    Foot

    Quick Drying
    Antifungal Formula

    WITH A UNIQUE BLEND
    OF HERBS, ESSENTIAL OILS,
    TOPICAL NUTRIENTS

    STOPS ITCHING & BURNING
    ELIMINATES ODOR
    USE DAILY FOR PREVENTION

    CURES & PREVENTS MOST
    ATHLETE'S FOOT

    Ointment

    D E R M A

    Net Wt 21g / .75 OZ

    PRINCIPAL DISPLAY PANEL - 21 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70084-510
    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
    Echinacea Purpurea (UNII: QI7G114Y98)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Water (UNII: 059QF0KO0R)  
    Allantoin (UNII: 344S277G0Z)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Bentonite (UNII: A3N5ZCN45C)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HIBISCUS SYRIACUS BARK (UNII: U6PQI719P3)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    Kaolin (UNII: 24H4NWX5CO)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    Methylparaben (UNII: A2I8C7HI9T)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    Panthenol (UNII: WV9CM0O67Z)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Rosemary (UNII: IJ67X351P9)  
    Sage (UNII: 065C5D077J)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Thyme (UNII: CW657OBU4N)  
    TUSSILAGO FARFARA FLOWER (UNII: UEE27X2Q2M)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70084-510-011 in 1 CARTON12/05/2005
    121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C12/05/2005
    Labeler - Quantum, Inc. (044806305)