WINCO MAXIMUM STRENGTH HYDROCORTISONE (HYDROCORTISONE) CREAM [WINCO FOODS, LLC]

WINCO MAXIMUM STRENGTH HYDROCORTISONE (HYDROCORTISONE) CREAM [WINCO FOODS, LLC]
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NDC 67091-280-28
Set ID 6d89e1b1-9979-41fa-a688-1c3acc68fb11
Category HUMAN OTC DRUG LABEL
Packager WinCo Foods, LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient (in each gram)                                                            Purpose

    Hydrocortisone 1%............................................................................Anti-itch

  • PURPOSE

    Uses

    • for the temporary relief of itching associated with minor skin irritations, inflammation and rashed due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis
    • for temporary relief of external anal and genital itching
    • other uses of this product shold only be under the advice and supervision of a doctor
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • for the treatment of diaper rash. Consult a doctor
    • in the genital area if you have a vaginal discharge. Consult a doctor
  • WHEN USING

    When using this product

    • avoid contact with the eyes
    • do not use more than directed unless told to do so by a doctor
    • do not put directly into the rectum by using fingers or any mechanical device or applicator 
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor
    • rectal bleeding occurs
  • 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

    for itching of skin irritation, inflammation, and rashes:

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor

    for external anal and genital itching, adults:

    • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by pattin gor blotting with toilet tissue or soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    aloe vera gel, butylated hydroxytoluene, cetanol, liquid paraffin, methylparaebn, polyoxyethylene cetylether, propylene glycol, propylparaben, retinol palmitate oil, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol, tocopherol acetate

  • QUESTIONS

    Questions? or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4pm MST

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WINCO MAXIMUM STRENGTH HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-280
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-280-281 in 1 CARTON02/16/2015
    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 not finalpart34802/16/2015
    Labeler - WinCo Foods, LLC (056098817)

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