DUANE READE HYDROCORTISONE (HYDROCORTISONE) CREAM [DUANE READE]

DUANE READE HYDROCORTISONE (HYDROCORTISONE) CREAM [DUANE READE]
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NDC 24488-033-18
Set ID e442afb3-cecf-45d4-90b3-b6eafe12b7ee
Category HUMAN OTC DRUG LABEL
Packager Duane Reade
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients..........................Purpose

    Hydrocortisone 1%..........................Anti-Itch

  • 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 or 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 other 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 contract 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

    Petrolatum
  • PRINCIPAL DISPLAY PANEL

    Placeholder text

    DR_hydrocortisone_ointment_Max_Strength_ Label

  • INGREDIENTS AND APPEARANCE
    DUANE READE  HYDROCORTISONE
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-033
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-033-181 in 1 CARTON
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/18/2011
    Labeler - Duane Reade (961956229)
    Registrant - Creations Garden Natural Products (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products961956229manufacture

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