Label: HYDROCORTISONE ointment

  • NDC Code(s): 45802-276-03
  • Packager: Padagis Israel Pharmaceuticals Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 31, 2024

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

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

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

    For external use only

    Do not use

    for the treatment of diaper rash. Ask a doctor.
    in the genital area if you have a vaginal discharge. Ask a doctor.

    When using this product

    avoid contact with the eyes
    do not use more than directed unless told to do so by a doctor
    do not put directly into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    condition worsens
    rectal bleeding occurs
    symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

    Keep out of reach of children.

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

  • Directions

    for itching of skin irritation, inflammation, and rashes:
    adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    children under 2 years of age: do not use, ask a doctor
    for external anal and genital itching, adults:
    when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    apply to affected area not more than 3 to 4 times daily
    children under 12 years of age: ask a doctor
  • Other information

    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    aloe barbadensis leaf juice, white petrolatum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Relieves Itch Fast

    Water Resistant Formula Helps Protect Skin

    • Insect Bites

    • Skin Irritation

    • Rashes

    • Eczema & Psoriasis

    • Inflammation & Redness

    Compare to Cortizone • 10® active ingredient

    Hydrocortisone 1%

    Maximum Strength Anti-Itch Ointment

    NET WT 1 OZ (28 g)

    Padagis

    HYDROCORTISONE 1% CARTON IMAGE 1 OF 2
    HYDROCORTISONE 1% CARTON IMAGE 2 OF 2
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-276
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorWHITE (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-276-031 in 1 CARTON08/18/2011
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/18/2011
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)