Label: ALUVEA- urea cream

  • NDC Code(s): 0259-1139-80
  • Packager: Merz Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 04/11

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  • SPL UNCLASSIFIED SECTION

    (39% Urea Cream)

    RX ONLY

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  • DESCRIPTION

    Aluvea™ (urea) cream, 39% is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin.

    Each gram of Aluvea Cream contains 39% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax NF, glycerin 99.7% USP, isopropyl myristate, purified water, sorbitol 70% Solution USP, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate.

    CHEMICAL STRUCTURE

    Urea is diamide of Carbonic acid with the following structure:

    Chemical Structure

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  • CLINICAL PHARMACOLOGY

    Urea 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.

    PHARMACOKINETICS

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

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  • INDICATION AND USAGE

    Urea 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 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.

    Pregnancy

    Category C

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

    Nursing Mothers

    It is not known whether Aluvea 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 ADMINISTRATIONS

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

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  • KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN
  • HOW SUPPLIED

    Aluvea is supplied in an 8oz. bottle.

    NDC 0259-1139-80

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

    Protect from freezing.

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Merz Pharmaceuticals, LLC
    Greensboro, NC 27410

    5011457 12/10

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  • PRINCIPAL DISPLAY PANEL - 227g Carton

    NDC 0259-1139-80

    ALUVEA
    39% Urea Cream

    WITH UNIQUE
    CSP
    VEHICLE
    TECHNOLOGY

    FOR EXTERNAL USE ONLY

    8 oz. (227g)

    Rx ONLY

    Principal Display Panel - 227g Carton
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  • INGREDIENTS AND APPEARANCE
    ALUVEA 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0259-1139
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Urea (Urea) Urea 39 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Dimethyl isosorbide  
    Glycerin  
    Isopropyl Myristate  
    Sorbitol  
    Tridecyl Stearate  
    Neopentyl Glycol Dicaprate  
    Tridecyl Trimellitate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0259-1139-80 1 in 1 CARTON
    1 227 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 04/15/2011
    Labeler - Merz Pharmaceuticals, LLC (126209282)
    Establishment
    Name Address ID/FEI Business Operations
    Crown Laboratories, Inc. 079035945 MANUFACTURE
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