Label: DUANE READE HYDROCORTISONE PLUS 12 MOISTURIZERS- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 28, 2011

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  • 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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