Label: HYDROCORTISONE- hydrocortisone acetate cream

  • NDC Code(s): 50332-0042-1, 50332-0042-2, 50332-0042-4
  • Packager: HART Health
  • 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 11/12

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  • ACTIVE INGREDIENT

    Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

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  • PURPOSE

    Purpose: anti-itch cream

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  • WARNINGS

    Warnings: For external use only. Do not get in eyes

    Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately clal 911 or your local emergency provider.

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  • DO NOT USE

    Do not use:

    • in the eyes or over large portions of the body
    • for the treatment of diaper rash
    • with any other hydrocortisone product

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  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens
    • condition lasts for more than 7 days
    • symptoms clear up and occur again within a few days
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

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  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and over: apply topically to the area 3 to 4 times daily.

    Children under 12 years of age: do not use, ask a doctor

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Cetyl Alcohol, Citric Acid, Diazolidinyl Urea, Edetate Disodium, Glycerin, Glyceryl Monostearate, Methylparaben, Mineral Oil, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine

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  • PRINCIPAL DISPLAY PANEL

    Hydrocort.jpg

    Hydrocort.jpg

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  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone acetate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50332-0042
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ALCOHOL  
    CITRIC ACID ACETATE  
    DIAZOLIDINYL UREA  
    EDETATE DISODIUM  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    METHYLPARABEN  
    MINERAL OIL  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    STEARIC ACID  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0042-1 10 in 1 BOX, UNIT-DOSE
    1 0.9 g in 1 PACKET
    2 NDC:50332-0042-2 25 in 1 BOX, UNIT-DOSE
    2 0.9 g in 1 PACKET
    3 NDC:50332-0042-4 144 in 1 BOX, UNIT-DOSE
    3 0.9 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/30/1990
    Labeler - HART Health (069560969)
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