Label: GENUINE 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 29, 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.

  • 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.

  • Keep out of reach of children

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

  • SPL UNCLASSIFIED SECTION

    GFA Production Xiamen Co., Ltd
    No. 20 Huli Industrial Park, Meixi Road,
    Tong'an, Xiamen, Fujian, China 361100

    Wellkang Ltd t/a Wellkang Tech Consulting
    Suite B, 29 Harley Street
    LONDON W1G 9QR, England, United Kingdom

    Copyright (c) 2010 GFA Production Xiamen Co., Ltd

    All rights reserved


  • PRINCIPAL DISPLAY PANEL

    Genuine Hydrocortisone Cream

    Maximum Strength

    Anti Itch



    Active ingredient:

    Hydrocortisone Acetate

    (equivalent to Hydrocortisone 1%)


  • PRINCIPAL DISPLAY PANEL

    Genuine Hydrocortisone Cream - Individual

  • PRINCIPAL DISPLAY PANEL

    Genuine Hydrocortisone Cream- Box

  • INGREDIENTS AND APPEARANCE
    GENUINE HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-2903
    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:52124-2903-10.9 g in 1 PACKET
    2NDC:52124-2903-2100 in 1 BOX
    20.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/29/2011
    Labeler - Genuine First Aid, LLC (619609857)
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