Label: ATHLETES FOOT ANTIFUNGAL- tolnaftate cream

  • 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 25, 2020

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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 FINALpart333C10/01/2017
    Labeler - Dollar General (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(55910-341)
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