Label: TOLNAFTATE ANTIFUNGAL- tolnaftate powder

  • NDC Code(s): 57896-199-45
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • Active ingredient

    Tolnaftate 1%

  • PURPOSE

    ANTIFUNGAL

  • USES

    • for effective treatment of most athlete’s foot (tinea pedis)

    and ringworm (tinea corporis)
    • for effective relief of itchy, scaly skin between the toes
    • clears up most athlete’s foot infection and with daily
    use helps keep it from coming back

  • 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 the eyes
    Stop use and consult a doctor if
    • irritation occurs
    • there is no improvement within 4 weeks

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    • shake well before use

    • 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
    • use daily for 4 weeks. If condition persists longer,
    consult a doctor.

    For athlete's foot

    • pay special attention to the spaces between the toes
    • wear well-fitting ventilated shoes
    • change shoes and socks at least once daily
    • to prevent athlete’s foot, clean and dry feet thoroughly.
    Apply as above once or twice daily.
    This product is not effective on the scalp or nails.

  • Other Information

    • store at room temperature

  • INACTIVE INGREDIENTS

    corn starch and talc

  • PACKAGE LABEL

    1

  • INGREDIENTS AND APPEARANCE
    TOLNAFTATE ANTIFUNGAL 
    tolnaftate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-199
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-199-4545 g in 1 BOTTLE, DISPENSING; Type 7: Separate Products Requiring Cross Labeling08/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/01/2011
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(57896-199)