Label: DERMASORB XM COMPLETE KIT- urea cream with moisturizing cream

  • NDC Code(s): 0316-0204-01, 0316-1035-01
  • Packager: Crown Laboratories
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/13

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

  • DESCRIPTION

    DERMASORB™XM (Urea 39%) Cream is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin. Each gram contains 390 mg Urea as the active ingredient and the following inactive ingredients: Dimethyl Isosorbide, Emulsifying Wax NF, Glycerin, Isopropyl Myristate, Purified Water, Sorbitol, Tridecyl Stearate and Neopentyl Glycol Dicaprylate/Dicaprate and Tridecyl Trimellitate.

    Urea is diamide of carbonic acid with the following structure:

    Urea Structure

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  • CLINICAL PHARMACOLOGY

    Urea cream gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.

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  • PHARMACOKINETICS

    The exact mechanism of action of topically applied urea is not known.

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  • INDICATION AND USAGE

    DERMASORB™XM (Urea 39%) Cream is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

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  • CONTRAINDICATIONS

    Known hypersensitivity to any of the listed ingredients.

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  • WARNINGS

    For external use only. Avoid contact with eyes, lips or mucous membranes.

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  • PRECAUTIONS

    Urea cream should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use.

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  • Pregnancy: Category C

    Animal reproduction studies have not been conducted with urea cream. It is also not known whether urea cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Urea cream should be given to a pregnant woman only if clearly needed.

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  • Nursing Mothers

    It is not known whether urea cream is excreted in human milk, therefore caution should be exercised when administering to a nursing mother.

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  • ADVERSE REACTIONS

    Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication.

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  • DOSAGE AND ADMINISTRATION

    Apply to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.

    KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN

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  • HOW SUPPLIED

    DERMASORB™XM (Urea 39%) Cream is supplied in:

    227g NDC 0316-0204-01

    Store at room temperature 15˚C - 30˚C (59˚F - 86˚F).

    Protect from freezing.

    Manufactured and distributed by: Crown Laboratories, Inc. Johnson City, TN 37604

    Rx Only

    P9471.00

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  • Dermasorb XM Complete Kit

    p947400

    Dermasorb XM Trade Carton

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  • INGREDIENTS AND APPEARANCE
    DERMASORB XM COMPLETE KIT 
    urea cream with moisturizing cream kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0316-1035
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0316-1035-01 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE, PLASTIC 227 g
    Part 2 1 TUBE 227 g
    Part 1 of 2
    DERMASORB XM 
    39% urea cream cream
    Product Information
    Item Code (Source) NDC:0316-0204
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UREA (UREA) UREA 390 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHYL ISOSORBIDE  
    POLAWAX POLYSORBATE  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    WATER  
    SORBITOL  
    TRIDECYL STEARATE  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE  
    TRIDECYL TRIMELLITATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0316-0204-01 1 in 1 KIT
    1 227 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/14/2013
    Part 2 of 2
    DERMASORB EXTREME MOISTURIZER 
    lotions, oils, powders, and creams
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR PETROLATUM  
    INGR GLYCERIN  
    INGR LIGHT MINERAL OIL  
    INGR CETYL ALCOHOL  
    INGR STEARYL ALCOHOL  
    INGR POLYOXYL 20 CETOSTEARYL ETHER  
    INGR SODIUM P-CHLORO-M-CRESOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 in 1 KIT
    1 227 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 11/14/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/14/2013
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
    Establishment
    Name Address ID/FEI Business Operations
    Crown Laboratories 079035945 manufacture(0316-1035)
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