Label: FUNGUS RELIEF SWABS - tolnaftate liquid 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredient

    Tolnaftate 1%

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  • Purpose

    Antifungal

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  • 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.
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  • 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.
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  • Keep out of the reach of children

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

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  • 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.
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  • Other information


    Avoid storing at excessive heat.

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  • Inactive Ingredients

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

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  • PRINCIPAL DISPLAY PANEL

    Image of carton label

    Image of fungus carton label

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  • INGREDIENTS AND APPEARANCE
    FUNGUS RELIEF SWABS  
    tolnaftate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65734-348
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    BUTYLATED HYDROXYTOLUENE  
    BUTYLENE GLYCOL  
    DIAZOLIDINYL UREA  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    METHYLPARABEN  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65734-348-36 5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 03/01/2003
    Labeler - Swabplus Inc. (876441549)
    Registrant - Swabplus Inc. (876441549)
    Establishment
    Name Address ID/FEI Business Operations
    Swabplus Inc. 876441549 manufacture(65734-348), relabel(65734-348), repack(65734-348)
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