Label: DERMATOOL FUNGAL NAIL TREATMENT- tolnaftate 1% liquid

  • NDC Code(s): 84728-510-01, 84728-510-02, 84728-510-03
  • Packager: Papalo Group LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2025

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  • ACTIVE INGREDIENT

    Tolnaftate 1%

  • PURPOSE

    Antifungal

  • INDICATIONS & USAGE

    Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning, redness, sorenes, and irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

  • 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 ask a doctor if: irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    For athlete's foot and ringworm: use daily for 4 weeks. 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. This product is not effective for the treatment of ringworm of the scalp or nails. 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. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.

  • INACTIVE INGREDIENT

    Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Oryza Sativa (Rice) Bran Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Simmondsia Chinensis (Jojoba) Seed Oil, BHT.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    DERMATOOL FUNGAL NAIL TREATMENT 
    tolnaftate 1% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84728-510
    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
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84728-510-011 in 1 CARTON04/06/2023
    115 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:84728-510-022 in 1 BOX01/31/2025
    215 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    3NDC:84728-510-033 in 1 BOX02/03/2025
    315 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/06/2023
    Labeler - Papalo Group LLC (119324672)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(84728-510)