Label: HYDROCORTISONE cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 28, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Warnings

    For external use only

  • Do not use

    • in eyes
    • for treatment of diaper rash
  • Stop use, as a doctor

    • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
    • with use of other hydrocortisone products
  • Keep out of reach of children.

    If ingested, contact a Poison Control Center right away

  • Directions

    • apply to affected area not more than 3 to 4 times daily
    • children under 2: ask a doctor
  • Inactive ingredients

    Emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

  • ACTIVE INGREDIENT

    Hydrocortisone 1.0%

  • USES:

    For temporary relief of itching associated with minor skin irritations, inflammation or rashes. Other uses of product should be only under the advice and supervision of a doctor.

  • PRINCIPLE DISPLAY PANEL

    HYDROCORTISONE CREAM

    1/32 oz. (0.9g)

    Dist by:UniShield

    San Fernando, CA 91340

    ACTIVE INGREDIENT

    Hydrocortisone 1.0%

    USES: For temporary relief

    of itching associated with

    minor skin irritations, inflammation or rashes.

    Other uses of product

    should be only under

    the advice and supervision

    of a doctor.

    PRINCIPLE DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-5801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    paraffin (UNII: I9O0E3H2ZE)  
    petrolatum (UNII: 4T6H12BN9U)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    PEG-150 distearate (UNII: 6F36Q0I0AC)  
    steareth-20 (UNII: L0Q8IK9E08)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-5801-00.8 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34807/28/2010
    Labeler - UniShield (790677053)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
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