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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 18, 2023

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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 finalpart333C01/01/2024
    Labeler - Family Dollar Stores, Inc (024472631)
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