DUANE READE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [DUANE READE]

DUANE READE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [DUANE READE]
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NDC 24488-032-17
Set ID 28e98f18-97f1-4b55-99b1-678af0bb729c
Category HUMAN OTC DRUG LABEL
Packager Duane Reade
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredient........................Purpose

    Hydrocortison 1%........................Anti-itch

  • Uses

    temporarily relief of itching associated with minor skin irritations and rashes due to

    • eczema
    • insect bites
    • poison ivy, poison oak, and poison sumac
    • soaps
    • detergents
    • cosmetics
    • 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

    • vaginal discharge
    • rectal bleeding
    • diaper rash
  • When using this product

    consult a doctor before exceeding the 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 another 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

    Adult and children 2 years of age and older:

    • apply to the affected area no more than 3-4 times daily
    children under 2 years: 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

    purified water/aqua/eau; glyceryl stearate and peg-100 stearate; c12-15 alkyl benzoate; isopropyl myristate; cetearyl alcohol and ceteareth-20; magnesium aluminium silicate; aloe barbadensis leaf juice; cholecalciferol (vitamin d3); citric acid; polysorbate 80; retinyl (vitamin a) palmitate; tocopheryl (vitamin e) acetate; propylene glycol; diazolidinyl urea; methylparaben; propylparaben

  • Questions?

    Call 1-866-375-6925

  • PRINCIPAL DISPLAY PANEL

    place holder text

    DR_Hydrocort_12Moist_Label

  • INGREDIENTS AND APPEARANCE
    DUANE READE  HYDROCORTISONE PLUS 12 MOISTURIZERS
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE.284 g  in 287.4 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-032-171 in 1 CARTON
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/28/2011
    Labeler - Duane Reade (961956229)
    Registrant - Creation's Garden Natural Products (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creation's Garden Natural Products961956229manufacture

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