Label: DR. ANTI FUNGUS- antifungal solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 13, 2024

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  • ACTIVE INGREDIENT

    Tolnaftate 1%

  • PURPOSE

    Antifungal. Prevents athlete's foot with use.

  • INDICATIONS & USAGE

    For effective treatment of most athlete's foot (dermatophytosis). Relieves: Itching, burning, scaling, irritation, soreness.

  • INACTIVE INGREDIENT

    Ethanol, Polysorbate 20, Polyethylene Glycol 300, Methylparaben.

  • WARNINGS

    1. Do not use on children under 2 years of age unless directed by a doctor.

    2. For external use only.

    3. Avoid contact with the eye.

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

  • DOSAGE & ADMINISTRATION

    Fill foot basin with warm water and add 1 oz of solution (1.5 tbsp) for every one gallon of water. Mix until water is diluted with the solution. Soak your feet for 5-10 minutes.

  • KEEP OUT OF REACH OF CHILDREN

    WARNINGS - Keep children out of reach.

  • PRINCIPAL DISPLAY PANEL

    Dr Anti Fungus

  • INGREDIENTS AND APPEARANCE
    DR. ANTI FUNGUS 
    antifungal solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65112-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.01 mg  in 236.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.2 mg  in 236.6 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65112-300-01236.6 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/01/2024
    Labeler - I. Shay Cosmetics (151582384)