Label: DUANE READE HYDROCORTISONE- 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 18, 2011

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  • 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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