Label: WINCO HYDROCORTISONE- hydrocortisone 1% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 6, 2022

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  • Drug Facts 

  • Active Ingredient 

    Hydrocortisone 1.0%

  • Purpose 

    Anti-Itch 

  • Uses

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

    • eczema
    • insect bites
    • poison ivy
    • poison oak
    • poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • external feminine, genital and anal itching.

    Other uses of this product should be only under the advice and supervision of a doctor.

  • Warnings 

    For external use only

  • Do not use

    • for the treatment of diaper rash, consult a doctor.
    • for external genital itching if you have a vaginal discharge, consult a doctor.
  • When using this product 

    • avoid contact with eyes
    • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
    • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
    • do not put this product into the rectum by using fingers or any mechanical device or applicator.
  • Directions

    • Adults and children 2 years and older
    • apply to affected area not more than 3 to 4 times daily.
  • Stop use and ask a doctor if

    • If condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

     Aloe Barbadensis Leaf Juice, Aluminum Sulfate, Beeswax, Calcium Acetate, Cetearyl Alcohol, Dextrin, Glycerin, Maltodextrin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Purified Water

  • Principal Display panel-Tube 

      WINCO                                                    NDC 67091-055-28

    MAXIMUM STRENGTH

    HYDROCORTISONE CREAM with aloe 

    Hydrocortisone 1%

    NET WT. 1 OZ (28G) 

    2502050_Winco_1oz_hydrocortisone_tube.jpg

  • Principal Display Panel - Carton 

    WINCO NDC 67091-055-28

    MAXIMUM STRENGTH

    HYDROCORTISONE CREAM with aloe

    Hydrocortisone 1%

    NET WT. 1 OZ (28G)

    557150_Winco_1oz_Hydrocortisone_Carton.jpg

  • INGREDIENTS AND APPEARANCE
    WINCO HYDROCORTISONE 
    hydrocortisone 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALCIUM ACETATE (UNII: Y882YXF34X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-055-281 in 1 CARTON04/30/2022
    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 finalpart34804/30/2022
    Labeler - WinCo Foods LLC (056098817)
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