WESTERN FAMILY HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [WESTERN FAMILY FOODS INC]

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  • WESTERN FAMILY HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [WESTERN FAMILY FOODS INC]

WESTERN FAMILY HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [WESTERN FAMILY FOODS INC]
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NDC 55312-063-02
Set ID 45be083c-5330-4526-8378-db67243408c6
Category HUMAN OTC DRUG LABEL
Packager Western Family Foods Inc
Generic Name
Product Class
Product Number
Application Number PART348
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  • 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).

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    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 PLUS
    12 MOISTURIZERS

    NET WT 1 OZ (28g)
    MAXIMUM STRENGTH

    Principal Display Panel - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY   HYDROCORTISONE PLUS 12 MOISTURIZERS
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-063-021 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/03/1989
    Labeler - Western Family Foods Inc (192166072)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(55312-063)
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