Label: HYDROSKIN- hydrocortisone cream 

  • 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 01/13

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

    • 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
    • for external anal itching, do not use more than directed. In case of bleeding, consult a doctor promptly 
    • do not insert cream 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

    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 15°-30°C (59°-86°F)
    • see box or crimp of tube for lot number and expiration date
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  • Inactive ingredients

    emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol solution, Preservative: benzyl alcohol

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  • Questions or comments?

    1-800-645-2158

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  • Principal Display Panel

    Maximum Strength

    Anti-Itch Cream

    1% Hydrocortisone Anti-Itch Cream

    HydroSkin 1% Cream

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  • INGREDIENTS AND APPEARANCE
    HYDROSKIN 
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-5108
    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
    BENZYL ALCOHOL  
    GLYCERIN  
    WATER  
    ISOPROPYL PALMITATE  
    LACTIC ACID  
    SORBITOL  
    Product Characteristics
    Color WHITE (Off white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-5108-95 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 10/29/2012
    Labeler - Rugby Laboratories (191427277)
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