Label: HYDRO SKIN- hydrocortisone lotion

  • 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  

    • for temporary relief of 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. Do not begin use of any other hydrocortisone product unless you have consulted 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

    shake well before use

    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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  • Inactive ingredients

    benzyll alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol 70% solution

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  • Questions or comments?

    1-800-645-2158

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  • Package/Label Principal Display Panel

    Rugby Laboratories

    Maximum Strength

    Anti-Itch Lotion

    hydrocortisone 1%

    Hydro Skin 1% Lotion

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  • INGREDIENTS AND APPEARANCE
    HYDRO SKIN 
    hydrocortisone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-5105
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    BENZYL ALCOHOL  
    GLYCERIN  
    ISOPROPYL PALMITATE  
    LACTIC ACID  
    SORBITOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-5105-97 118 mL in 1 BOTTLE
    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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