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Western Family (Western Family Foods Inc)

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CREAM 1 TUBE in 1 CARTON (55312-013-02) > 28 g in 1 TUBE Label Information

Complete Western Family 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, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol


  • Questions?

    Call 1-866-923-4914


  • SPL UNCLASSIFIED SECTION

    Proudly Distributed By:
    Western Family Foods, Inc.
    P.O. Box 4057, Portland, OR 97208


  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    HydroCortisone
    1% Hydrocortisone Anti-Itch CREAM

    NET WT 1 OZ (28g)

    MAXIMUM STRENGTH

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY   HYDROCORTISONE
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-013
    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)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    paraffin (UNII: I9O0E3H2ZE)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55312-013-02 1 in 1 CARTON
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/23/1995
    Labeler - Western Family Foods Inc (192166072)
    Registrant - Taro Phamaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Phamaceuticals Inc. 206263295 MANUFACTURE(55312-013)