Label: KAISER PERMANENTE  HYDROCORTISONE- hydrocortisone acetate cream 

  • Label RSS
  • NDC Code(s): 0179-8710-30
  • Packager: Kaiser Foundation Hospitals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

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  • Purpose

    Anti-itch cream

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  • Uses

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

    For external use only

    Do not use

    • in the eyes
    • by putting this product into the rectum by using fingers or any mechanical device or applicator

    Ask a doctor before use if you have

    • a vaginal discharge
    • rectal bleeding
    • diaper rash

    When using this product consult a doctor before exceeding recommended dosage

    Stop use and ask a doctor if

    • condition gets worse
    • condition persists for more than 7 days
    • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    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

    For external anal itching

    • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

    Children under 12 years of age: consult a doctor

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  • Other information

    • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
    • store at room temperature
    • see carton or tube crimp for lot number and expiration date
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  • Inactive ingredients

    cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    Manufactured by
    Taro Pharmaceuticals Inc.
    Brampton, Ontario, Canada L6T 1C1
    Distributed by
    Kaiser Foundation Hospitals
    Livermore, CA 94551-9756

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  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    KAISER PERMANENTE®

    Hydrocortisone 1% Cream
    HYDROCORTISONE ACETATE | ANTIPRURITIC (ANTI-ITCH)
    ITCH AND RASH RELIEF

    NET WT 1 OZ (28.4 g)

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    KAISER PERMANENTE   HYDROCORTISONE
    hydrocortisone acetate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0179-8710
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone acetate (Hydrocortisone) Hydrocortisone acetate 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CETOSTEARYL ALCOHOL  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM LAURYL SULFATE  
    PETROLATUM  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0179-8710-30 1 in 1 CARTON
    1 28.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/01/2001
    Labeler - Kaiser Foundation Hospitals (053052619)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(0179-8710)
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