DUANE READE (HYDROCORTISONE) CREAM [DUANE READE]

DUANE READE (HYDROCORTISONE) CREAM [DUANE READE]
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NDC 24488-034-19
Set ID bd78a65a-b416-4664-81b2-7b4501cc7470
Category HUMAN OTC DRUG LABEL
Packager Duane Reade
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredient..........................Purpose

    Enter section text here

  • 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
    • conditions 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 12 years of age: 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
    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 INGREDIENT

    purified water/aqua/eau; glyceryl stearate and peg-100 stearate; c12-15 alkyl benzoate; isopropyl myristate; cetearyl alcohol and ceteareth-20; magnesium aluminum silicate; aloe barbadensis leaf juice; citric acid; polysorbate 80; sodium lauryl sulfate; propylene glycol,diazolidinyl urea, methlyparaben, propylparaben

  • Questions?

    Call 1-866-923-4914

  • PRINCIPAL DISPLAY PANEL

    Placeholder text

    DR_Hydrocort_Crm_Aloe1oz_label





  • INGREDIENTS AND APPEARANCE
    DUANE READE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE.284 g  in 28.4 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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-034-191 in 1 CARTON
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/21/2011
    Labeler - Duane Reade (961956229)
    Registrant - Creation's Garden Natural Products (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creation's Garden Natural Products961956229manufacture

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