Label: HYDROCORTISONE ointment

  • NDC Code(s): 0168-0181-31
  • Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
  • 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 September 12, 2019

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

  • Active Ingredient (in each gram):

    Hydrocortisone 10 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

    mineral oil and white petrolatum

  • 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
    W5160B
    R12/11
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    Fougera®

    NDC 0168-0181-31

    HYDROCORTISONE OINTMENT USP, 1%

     
    ANTI-ITCH OINTMENT
    MAXIMUM STRENGTH
    available without prescription

    NET WT 28.35g (1 Oz)

    labeltube
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

    Fougera®

    NDC 0168-0181-31

    HYDROCORTISONE OINTMENT USP, 1%

     
    ANTI-ITCH OINTMENT
    MAXIMUM STRENGTH
    available without prescription

    NET WT 28.35g (1 Oz)

    CARTON
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0181
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    mineral oil (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0181-311 in 1 CARTON04/06/197512/31/2021
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/06/197512/31/2021
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)