Label: SHOPKO HYDROCORTISONE WITH ALOE- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL

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 December 31, 2012

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  • ACTIVE INGREDIENT

    Active ingredient                                                                       Purpose

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

  • PURPOSE

    Uses for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

    • eczema
    • seborrheic dermatitis
    • psoriasis
    • insect bites
    • poison ivy, oak, sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • external genital, feminine and anal itching.
    Other uses of this product should be only under the advice and supervision of a doctor
  • WARNINGS

    Warnings

    • for external use only
    • avoid contact with eyes
  • STOP USE

    Stop using this product 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
    • before you begin using any other hydrocortisone product
  • DO NOT USE

    Do not use this product and ask a doctor

    • if you have a vaginal discharge
    • before treating diaper rash
    • before using on children under 2 years of age
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

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

    Before using any medication, read all label directions.  Keep this carton.  It contains important information.
  • INDICATIONS & USAGE

    Directions

    • for 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: do not use, consult a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • Lot No. and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Vera Gel, Butylated Hydroxytoluene, Cetanol, Liquid Paraffin, Methylparaben, Polyonyethylene Cetylether, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Monostearate, Stearyl Alcohol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp

    17211 Valley View Ave.

    Cerritos, CA 90703

    www.ueccorp.com


    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    SHOPKO HYDROCORTISONE WITH ALOE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-699
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-699-281 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/31/2012
    Labeler - UNITED EXCHANGE CORP (840130579)
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