Label: TOLNAFTATE- antifungal liquid maximum strength liquid

  • NDC Code(s): 56104-242-01
  • Packager: Premier Brands of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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  • ​Active ingredient

    Tolnaftate 1% w/w

  • ​Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • prevents the recurrences of 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 eyes.

    Stop use and consult a doctor if

    • irritation occurs
    • there is no improvement in 4 weeks

    Keep out of reach 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 condition persists longer, consult a doctor
    • to prevent athlete's foot: wash the feet 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

    Water, Acrylates Copolymer, Glycerin (RSPO), Phenoxyethanol, Tocopherol, Sodium Hydroxide, Ethylhexyglycerin

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    Premier

    MAXIMUM

    STRENGTH

    ANTIFUNGAL

    LIQUID

    Tolnaftate 1%

    Proven clinically

    effective in the cure

    & prevention of

    fungus on fingers,

    toes & around nails

    Relieves itching,

    burning & scaling

    With moisturizer

    Built-in brush for

    easy appplication

    NET WT 1 FL OZ (30 mL)

    nail solution 1

    nail solution 2

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE 
    antifungal liquid maximum strength liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-242
    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
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-242-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product03/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/05/2021
    Labeler - Premier Brands of America, Inc. (117557458)
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