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SAFEWAY (Safeway Inc.)

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CREAM 1 TUBE in 1 CARTON (21130-063-02) > 28.4 g in 1 TUBE Label Information

Complete SAFEWAY Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    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

    aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate)


  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY SAFEWAY INC.
    P.O. BOX 99
    PLEASANTON, CA 94566-0009

    1-888-SAFEWAY


  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    Maximum Strength

    NDC 21130-063-02

    Compare to the active
    ingredient in Cortizone
    ●10® Plus and Cortaid ®
    Intensive Therapy*

    Hydrocortisone 1% Cream Plus 12 Moisturizers

    Antipruritic (Anti-Itch)
    ● Itch and Rash Relief ● Enriched With Vitamins A, D & E

    NET WT 1 OZ (28.4 g)

    SAFEWAYâ„¢

    Principal Display Panel - 28.4 g Tube Carton

  • INGREDIENTS AND APPEARANCE
    SAFEWAY   HYDROCORTISONE PLUS 12 MOISTURIZERS
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-063
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-063-02 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 10/03/1989
    Labeler - Safeway Inc. (009137209)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(21130-063)