Label: MAXIMUM STRENGTH ANTIFUNGAL LIQUID- tolnaftate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2024

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  • ​Active ingredient

    Tolnaftate 1% w/w

  • ​Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treament of most athlete's foot (tinea pedis) and ring worm (tinea corporis).
    • prevents the recurrence of most athlete's foot with daily use
    • for effective relief of itching, burning, cracking, redness and scaling,
  • Warnings

    For external use only.

    Do not use

    on children under 2 years of age unless directed by a doctor.

    When using this product

    avoid contact with the eyes.

    Stop use and consult a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks.

    Keep out of reach of children.

    If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

  • ​Directions

    • clean the affected area and dry thoroughly.
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
    • supervise children in the use of this product.
    • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    • for athlete's foot and ringworm, use daily for 4 weeks.
    • If condition persists longer, consult a doctor.
    • to prevent athlete's foot: wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails.
  • ​Other information​

    • SHAKE WELL BEFORE USE
    • store at room temperature 15°-30°C (59° - 86°F)
    • protect from freezing; if freezing occurs, warm to room temperature
    • keep tightly closed when not in use.
  • ​Inactive ingredient

    WATER, GLYCERIN, SCLEROTIUM GUM, PHENOXYETHANOL, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, XANTHAN GUM

  • Questions?

    Call 1-877-237-0194

  • Principal Display Panel

    comfort zone

    maximum strength

    antifungal liquid

    tolnaftate 1%/antifungal

    Prevents the recurrence

    of most athlete's foot

    with daily use

    Proven clinically effective

    in the treatment of fungus

    on fingers, toes and skin

    around nails

    relieves itching, burning & scaling

    with moisturizing ingredients

    built-in applicator brush

    SHAKE WELL BEFORE USE

    1 FL. OZ.

    (30 mL)

    cartonlabel

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH ANTIFUNGAL LIQUID 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72446-013
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72446-013-011 in 1 CARTON10/17/2024
    130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/17/2024
    Labeler - Hudson Health LLC (081276171)