Label: FUNGUS RELIEF- tolnaftate solution

  • Category: HUMAN OTC DRUG LABEL

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 January 28, 2015

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  • Drug Facts

    Active Ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • Cures fungal infections of the toes and fingers, including skin around and under nails, where accessible with swab applicator. Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) and relieves symptoms of athlete's foot including itching, burning and scaly skin.
    • Help prevent most athlete's foot from recuring when uses daily.
  • Warings

    For external use only.
    When using this product avoid contact with eyes.
    Stop use and ask a doctor if irritation occurs. there is no improvement within 4 weeks.
    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

  • Keep out of the reach of children

    If swallowed get  medical help or contact a Poison Control Center right away.

  • Directions

    • Do not use if label seal is broken prior to purchase.
    • Keep swabs in original container when not in use.
    • wash affected area and dry thoroughly.
    • Hold the swab vertically with the color band tip upwards.
    • Bend the tip at the color band to one side until it snaps.
    • Apply a thin layer over affected area twice daily (morning and night)
    • Discard swab after use.
    • For athlete's foot, apply once or twice daily, pay special attention to spaces between toes, wear shoes with good ventilation and change shoes and socks at least once 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


    Avoid storing at excessive heat.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract. BHT. Butylene Glycol, Diazolidinyl Urea, Ethoxydiglycol, Methylparaben, Propylene Glycol, Propylparaben. Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    Image of carton label

    Image of fungus carton label

  • INGREDIENTS AND APPEARANCE
    FUNGUS RELIEF  
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-348
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65734-348-3636 in 1 PACKAGE
    1NDC:65734-348-000.15 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/01/2003
    Labeler - Swabplus Inc. (876441549)
    Registrant - Swabplus Inc. (876441549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swabplus Inc.876441549manufacture(65734-348) , relabel(65734-348) , repack(65734-348)
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