Label: WINCO FOODS TOLNAFTATE- 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 28, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (in each gram)  Purpose

    Tolnaftate 1%--------------------------------------------------------------------------------- Antifungal

  • PURPOSE

    Uses

    • Proven clinically effective in the treatment of athlete's foot (tinea pedis) and rignworm (tinea corporis)
    • Helps prevent most athlete's foot with daily use
    • For effective relief of itching, burning and cracking
  • WARNINGS

    Warnings:

    For external use only

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

  • WHEN USING

    When using this product

    Avoid contact with the eyes.

  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • INDICATIONS & USAGE

    Directions

    • wash affected area and dry thoroguhly
    • 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 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 SAFETY INFORMATION

    Other information

    • store between 20° to 25C° (68° to 77F°)
    • Lot No & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    buylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WINCO FOODS, LLC,

    BOISE, ID 83704

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    24193

  • INGREDIENTS AND APPEARANCE
    WINCO FOODS TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-276
    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
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-276-281 in 1 BOX05/11/2017
    128 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/06/2015
    Labeler - Winco Foods, LLC (056098817)
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