PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]

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  • PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]

PUBLIX HYDRO (HYDROCORTISONE) CREAM [PUBLIX SUPER MARKETS INC]
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NDC 41415-047-75
Set ID 29296b0f-0eed-4bb9-8727-c25c2bcf9fd6
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets 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, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY PUBLIX
    SUPER MARKETS, INC.
    3300 PUBLIX CORPORATE
    PARKWAY
    LAKELAND, FL 33811

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    Publix

    hydrocream
    1% HYDROCORTISONE
    ANTIPRURITIC (ANTI-ITCH)

    EFFECTIVE ITCH & RASH RELIEF WITH ALOE

    NET WT 1 OZ (28.4 g)

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PUBLIX   HYDRO
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-047
    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)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41415-047-751 in 1 CARTON
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34808/23/1995
    Labeler - Publix Super Markets Inc (006922009)
    Registrant - Taro Phamaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Phamaceuticals Inc.206263295MANUFACTURE(41415-047)
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