Label: DEFENSE ANTIFUNGAL MEDICATED BAR- tolnaftate soap

  • 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 November 29, 2017

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • Proven clinically effective in the treatment of most athlete's foot (tinea pedis) & ringworm (tinea corporis).
    • For effective relief of itching, burning & cracking.
  • Warnings

    For external use only

    When using this product

    When using this product avoid contact with the eye

    Stop use and ask a doctor if

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    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.

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

  • Directions

    • Wash affected area well and let product sit 1-2 minutes before rinsing.
    • 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.
  • Other information

    Store between 20 to 25C (68 to 77F)

  • Inactive ingredients

    Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Acid, Sodium Chloride, Palm Kernel Acid

  • Questions or comments?

    1-866-544-1689

    www.DefenseSoap.com

  • Principal Display Panel

    Tolnaftate 1%

    Antifungal
    Medicated Bar Soap
    Cures and Prevents Most Fungal Skin Infections, Including Athlete’s Foot, Ringworm and Tinea Versicolor.

    External box

  • INGREDIENTS AND APPEARANCE
    DEFENSE ANTIFUNGAL MEDICATED BAR 
    tolnaftate soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70856-3434
    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
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PALM ACID (UNII: B6G0Y5Z616)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70856-3434-31 in 1 CARTON08/01/2016
    1119 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/01/2016
    Labeler - Defense Soap LLC (780587353)
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