Label: ATHLETES FOOT ANTIFUNGAL- tolnaftate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 2, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • prevents the recurrence of most athlete's foot with daily use
    • relieves itching, burning, cracking, scaling, and discomfort that accompany these conditions
  • Warnings

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

    For external use only.

    Avoid contact with eyes.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or, contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in use of this product
    • 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
    • use daily for 4 weeks
    • if condition persists longer, ask a doctor
    • this product is not effective on scalp or nails
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

  • Questions or comments?

    1-888-309-9030

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY OLD EAST MAIN CO.,
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    DG™| health

    Compare to the active
    ingredient of TINACTIN®*

    Athlete's Foot Cream
    Antifungal Cream

    NET WT 1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT   ANTIFUNGAL
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-341
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE0.01 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-341-241 in 1 CARTON10/01/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00510/01/2017
    Labeler - Dollar General (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(55910-341)
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