Label: HYDROCORTISONE  - hydrocortisone cream 

  • NDC Code(s): 53210-1002-0
  • Packager: Morales Distributors 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 09/12

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

  • Active ingredient

    Hydrocortisone 1.0 percent

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  • Purpose

    Anti-Itch

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  • Uses

    temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to

    • eczema
    • psoriasis
    • seborrheic dermatitis
    • poison ivy, oak, sumac
    • insect bites
    • soaps and detergents
    • cosmetics
    • jewerly
    • external feminine and anal itching
    Other uses of this product: ask a doctor
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  • Warnings

    For external use only

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  • Do not use

    • in or near the eyes
    • by putting directly into the rectum by using fingers or any mechanical device or applicator
    • for external feminine itching if you have a vaginal discharge
    • for diaper rash; ask a doctor
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  • Ask a doctor or pharmacist

    before use if you are using any other hydrocortisone product

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  • When using this product

    for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

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  • Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • rectal bleeding occurs
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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control

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  • Directions

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

    store at room temperature, protect from freezing

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  • Inactive ingredients

    butylated hydroxytoluene, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, propylparaben, purified water, squalane, and stearic acid

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  • Principal Label

    NDC NO. 53210-1002-0
    Compare to maximum strength Cortaid(R) active ingredient

    Maximum Strength
    FAST RELIEF
    plus itching plus redness

    Anti-Itch Cream for Skin Irritations

    Relieves Itching and Redness Fast

    Hydrocortisone 1 percent Cream

    NET 1oz(28.3g)

    Exclusively distributed by:
    Morales Distributors, Inc
    Mayaguez, P.R. 00682

    This product is not manufactured or distributed by Pharmacia Consumer Healthcare, owner of the registered trademark Cortaid.(R)

    Made in Korea

    box label

    box label

    tube label

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  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE  
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53210-1002
    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
    BUTYLATED HYDROXYTOLUENE  
    CETYL ALCOHOL  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    ISOPROPYL MYRISTATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    WATER  
    SQUALANE  
    STEARIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53210-1002-0 1 in 1 BOX
    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 09/25/2012
    Labeler - Morales Distributors Inc (127151731)
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