WINCO FOODS TOLNAFTATE (TOLNAFTATE) CREAM [WINCO FOODS, LLC]

WINCO FOODS TOLNAFTATE (TOLNAFTATE) CREAM [WINCO FOODS, LLC]
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NDC 67091-276-28
Set ID 218f7613-1401-4f1b-bf46-576b536825af
Category HUMAN OTC DRUG LABEL
Packager Winco Foods, LLC
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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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