Label: TOE FUNGUS- tolnaftate solution

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

Drug Label Information

Updated April 16, 2024

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  • Active ingredient

    Tolnaftate

  • Ask a doctor

    If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor

  • Purpose

    Antifungal

  • Use

    Cures most fungus on toes

  • Keep out of reach of children

    Supervise children in the use of this product.

  • Stop Use Section

    If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

  • Directions

    • Wash the affected area and dry thoroughly.
    • Apply a thin layer of the product over affected are twice daily (morning and night) or as directed by a doctor.
    • Supervise children in the use of this product.
    • Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
    • If condition persists longer, consult a doctor.
  • Warnings

    • Do not use on children under 2 years of age unless directed by a doctor.
    • For external use only.
    • Avoid contact with the eyes.
    • If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • Other Information

    Store between 20 C and 30 C (68 F and 86 F)

  • Inactive Ingredients

    Alpha-Bisabolene, Chlorphenesin, Glycerin, Horse Chestnut, Jojoba Oil, Methyl Gluceth-20, Phenoxyethanol, Piroctone Olamine, Polyethylene Glycol 400, Polyoxyl 40 Hydrogenated Castor Oil, Squalene, Tea Tree Oil, Water

  • Principle Display Panel

    Version 3

  • INGREDIENTS AND APPEARANCE
    TOE FUNGUS 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83837-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SQUALENE (UNII: 7QWM220FJH) 0.1 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 0.3 g  in 100 mL
    .ALPHA.-BISABOLENE (UNII: SUQ209P6FX) 0.1 g  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.6 g  in 100 mL
    METHYL GLUCETH-20 (UNII: J3QD0LD11P) 3 g  in 100 mL
    JOJOBA OIL (UNII: 724GKU717M) 0.3 g  in 100 mL
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) 0.1 g  in 100 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 78 mL  in 100 mL
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB) 0.05 g  in 100 mL
    CHLORPHENESIN (UNII: I670DAL4SZ) 0.12 g  in 100 mL
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 15 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.365 g  in 100 mL
    TEA TREE OIL (UNII: VIF565UC2G) 0.3 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83837-001-0175 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/19/2024
    Labeler - Imperial Feet B.V. (386790021)
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