Label: TOLNAFTATE- anti-fungal liquid maximum strength liquid

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

Drug Label Information

Updated January 18, 2024

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (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 2 years of age unless directed by a doctor.

    When using this product

    avoid contact with eyes

    Stop use and consult a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    Keep out of children.

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

  • Directions

    Read all warnings and directions. Use only as directed.

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over the 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 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 conditions 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

    • 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

    Acrylates Copolymer, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Sodium Hydroxide, Tocopherol, Water

  • Questions?

    Call 1-877-237-0194

  • Principal Display Panel

    comfortzone

    maximum strength

    anti-fungal liquid

    tolnaftate 1%

    Proven clinically effective in the cure and prevention of fungus on fingers, toes & around nails

    • relieves itching burning & scaling
    • with moisturizer
    • built-in brush for easy application
    • 1 FL. OZ (30mL)

    boxlabel

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    anti-fungal liquid maximum strength liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72446-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.3 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72446-011-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00505/21/2021
    Labeler - Hudson Health LLC (081276171)
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