Label: EQUATE HYDROCORTISONE- hydrocortisone cream

  • NDC Code(s): 49035-541-16, 49035-541-64
  • Packager: Wal-Mart Stores Inc
  • 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 02/12

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
    • seborrheic dermatitis
    • soaps
    • external genital and anal itching
    • other uses of this product should be only under the advice and supervision of a doctor
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  • Warnings

    For external use only

    Do not use

    • for the treatment of diaper rash. Ask a doctor.
    • for external genital itching if you have a vaginal discharge. Ask a doctor.

    When using this product

    • avoid contact with the eyes
    • do not begin use of any other hydrocortisone product unless you have asked a doctor
    • for external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
    • 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
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

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

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  • Directions

    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 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 a soft cloth before application of this product.
    • children under 12 years of age with external anal itching: ask a doctor
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  • Other information

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

    aloe vera gel, ceteareth-20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, purified water

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  • Questions or comments?

    1-888-287-1915

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  • Principal Display Panel

    Compare to Cortaid® Active Ingredient

    Maximum Strength

    Hydrocortisone 1% Cream

    Anti-Itch Cream

    Relieves Itching and Redness Fast!

    Helps heal rashes for healthier skin

    Relieves Itches Due to:

    Eczema, Insect Bites, Psoriasis, Rashes, Seborrheic Dermatitis, Poison Ivy, Oak, Sumac

    Hydrocortisone 1% Cream Carton Image 1

    Hydrocortisone 1% Cream Carton Image 1

    Hydrocortisone 1% Cream Carton Image 2

    Hydrocortisone 1% Cream Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    EQUATE HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-541
    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  
    POLYOXYL 20 CETOSTEARYL ETHER  
    CETOSTEARYL ALCOHOL  
    CETYL PALMITATE  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    METHYLPARABEN  
    WATER  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-541-16 1 in 1 CARTON
    1 56 g in 1 TUBE
    2 NDC:49035-541-64 1 in 1 CARTON
    2 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 06/29/2005
    Labeler - Wal-Mart Stores Inc (051957769)
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