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KAISER PERMANENTE (Kaiser Foundation Hospitals)

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Dosage Form Package Information Links
CREAM 1 TUBE in 1 CARTON (0179-8710-30) > 28.4 g in 1 TUBE Label Information

Complete KAISER PERMANENTE Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Hydrocortisone acetate (equivalent to Hydrocortisone 1%)


  • Purpose

    Anti-itch cream


  • 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

  • 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.


  • 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


  • 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

  • Inactive ingredients

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


  • Questions?

    Call 1-866-923-4914


  • SPL UNCLASSIFIED SECTION

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


  • 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

  • INGREDIENTS AND APPEARANCE
    KAISER PERMANENTE   HYDROCORTISONE
    hydrocortisone acetate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0179-8710
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone acetate 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    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)