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 26, 2012

If you are a consumer or patient please visit this version.

  • Active Ingredient:

    Hydrocortisone 5 mg

  • Purpose:

    Anti-itch

  • INDICATIONS & USAGE

    Uses:

    • for temporary relief of itching associated with minor skin irritations and rashes due to:
    • eczema
    • insect bites
    • soaps and detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • poison ivy , oak or sumac
    • for external genital, feminine and anal itching
    • other uses of this product should be only under the advice and supervision of a doctor
  • WARNINGS

    Warnings:

    For external use only

    Do not use

    • in children under 2 years of age
    • if you have a vaginal discharge
    • for the treatment of diaper rash

    Ask a doctor before use if you have

    • external genital or feminine itching
    • external anal itching
    • bleeding

    When using this product

    • avoid contact with eyes
    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor

    • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and do not begin use of any other hydrocortisone product
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    For minor skin irritations and rashes,

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily .

    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 soft cloth before application of this product
    • children: under 12 years of age, consult a doctor.
  • SPL UNCLASSIFIED SECTION

    Other information:

    • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
    • store at room temperature
    • see crimp of tube for Lot Number and Expiration Date
  • Inactive Ingredients

    benzyl alcohol, glycerin, glyceryl monostearate, isopropyl palmitate, lactic acid, paraffin, polyoxyl 40 stearate, potassium sorbate, purified water, sorbitan monostearate and stearyl alcohol.

  • SPL UNCLASSIFIED SECTION

    Questions or comments? call toll free 1-800-645-9833

    E. FOUGERA & CO.

    A division of Fougera Pharmaceuticals Inc.

    Melville, NY 11747

    W5156B

    R11/11

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    Fougera®

    NDC 0168-0014-31

    HYDROCORTISONE CREAM USP, 0.5%

    ANTI-ITCH CREAM

    NET WT 28.35g (1 Oz)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

    Fougera®

    NDC 0168-0014-31

    HYDROCORTISONE CREAM USP, 0.5%

    ANTI-ITCH CREAM

    NET WT 28.35g (1 Oz)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    benzyl alcohol (UNII: LKG8494WBH)  
    glycerin (UNII: PDC6A3C0OX)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    lactic acid (UNII: 33X04XA5AT)  
    paraffin (UNII: I9O0E3H2ZE)  
    polyoxyl 40 stearate (UNII: 13A4J4NH9I)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    water (UNII: 059QF0KO0R)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0014-311 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/01/1968
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)