Label: 1 HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment

  • NDC Code(s): 41520-201-64
  • Packager: American Sales Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/13

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

  • Active ingredient

    Hydrocortisone 1%

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  • Purpose

    Anti-itch

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  • 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
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  • Warnings

    For external use only

    Do not use

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

    Keep out of reach of children.

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

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  • 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
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  • Other information

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

    aloe barbadensis leaf juice, white petrolatum

    Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the Active Ingredient in Cortizone●10®

    MAXIMUM STRENGTH

    1% HYDROCORTISONE

    ANTI-ITCH OINTMENT

    Relieves Itch Fast

    Skin Irritation – Rashes- Insect bites – Eczema & Psoriasis – Inflammation & Redness

    Water resistant formula helps seal in healing

    NET WT 1 OZ (28 g)

    CareOne 1% Hydrocortisone 1.jpg
    CareOne 1% Hydrocortisone 2.jpg
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  • INGREDIENTS AND APPEARANCE
    1 HYDROCORTISONE  MAXIMUM STRENGTH
    hydrocortisone ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-201
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    PETROLATUM  
    Product Characteristics
    Color WHITE (clear) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-201-64 1 in 1 CARTON
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/17/2012
    Labeler - American Sales Company (809183973)
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