Label: HYDROCORTISONE- hydrocortisone acetate 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 December 1, 2011

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  • Active Ingredient

    Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

  • Purpose

    Maximum strength Anti-itch

  • Uses

    For temporary relief of itching associated with minor skin irritations and rashes due to eczema, seborrheic dermatitis, insect bites, poison ivy, poison oak, poison sumac, sores, detergents, cosmetic and jewelry. Other uses of this product should be only under supervision of a physician.

  • Warnings

     For external use only.

  • Do not use:

    In eyes. On children under 2 years of age, unless under advice and supervision of a doctor.

    If condition persists for more than 7 days.

  • Keep out of reach of children

    If ingested, get medical help or contact a Poison Control Center immediately.


  • Directions

    Adults and Children 2 years and older apply to affected area no more than 4 times daily,

    Children under 2: Consult a doctor

  • Other Information

    Store at room temperature

    (Do not freeze)

  • Inactive Ingredients

    Propylene glycol, Carbomer, Purified water.

  • PRINCIPAL DISPLAY PANEL


    Genuine Hydrocortisone Cream

    Maximum Strength

    Anti-Itch

    Net Wt 0.9g (1/32 oz)

    Manufactured in CHINA for
    Genuine First Aid
  • Product Labeling

    Genuine Hydrocortisone Cream

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0007-10.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34804/23/2010
    Labeler - Genuine First Aid (619609857)
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