Label: FAMILY WELLNESS ATHLETES FOOT TOLNAFTATE 1 CREAM- tolnaftate cream

  • NDC Code(s): 55319-991-00
  • Packager: Family Dollar Stores, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 25, 2025

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

    Purpose

    Anti-Funga

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use
    • for effective relief of itching , burning , and cracking
  • Warnings

    For external use only.

    Do not use

    on children under 2 years of age except under the advice and supervision of a doctor.

    When using this product

    avoid contact with the eyes.

    Stop use and ask 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 immediately.

  • Directions

    • wash the affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in the use of this product.
    • for athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
    • use daily for 4 weeks; if condition persists longer, ask a doctor.
    • to prevent athlete's foot, apply once or twice daily (morning and/or night).
    • this product is not effective on the scalp or nails.
  • Other info rmation

    • store at room temperature 20°-25°C (68°-77°F).
    • lot no & expiration date: see box or crimp of tube
  • Inactive ingredients

    cetyl alcohol, ethylparaben, glycerol, glyceryl monostearate, mineral oil, petrolatum, purified water, sodium lauryl sulfate

  • Questions?

    1-800-639-3803Weekdays 9 AM to 4 PM EST

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS ATHLETES FOOT TOLNAFTATE 1 CREAM 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-991
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-991-001 in 1 BOX01/01/2024
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/01/2024
    Labeler - Family Dollar Stores, Inc (024472631)
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