Label: UREA- urea cream

  • NDC Code(s): 58980-605-30
  • Packager: Stratus Pharmaceuticals, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 04/10

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

  • SPL UNCLASSIFIED SECTION

    For external use only.
    Not for ophthalmic use.

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  • DESCRIPTION

    UREA 10% CREAM is a potent keratolytic emollient which is a gentle tissue softener for skin and/or nails.

    Each gram of UREA 10% CREAM contains 10% Urea in a cream base of Carbomer, Fragrance, Isopropyl Myristate, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearic Acid, Trolamine and Xanthan Gum.

    Chemical Structure
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  • CLINICAL PHARMACOLOGY

    Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

    PHARMACOKINETICS

    The mechanism of action of topically applied Urea is not yet known.

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  • INDICATIONS AND USES

    For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

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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

    If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

    PREGNANCY

    Pregnancy Category B

    Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, UREA 10% CREAM should be given to a pregnant woman only if clearly needed.

    NURSING MOTHERS

    It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when UREA 10% CREAM is administered to a nursing woman.

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  • ADVERSE REACTIONS

    Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

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  • DOSAGE AND ADMINISTRATION

    Apply UREA 10% CREAM to affected skin twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.

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  • HOW SUPPLIED

    UREA 10% CREAM is supplied in:

    85g (3 oz) tube      58980-605-30

    Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

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  • SPL UNCLASSIFIED SECTION

    Manufactured by:
     
    Sonar Products Inc.
    Carlstadt, NJ 07072
    Manufactured for:
     
    Stratus Pharmaceuticals Inc
    Miami, Florida 33186-6727
    Telephone: 800-442-7882
    www.stratuspharmaceuticals.com

    P-UC(10)-201004

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  • PRINCIPAL DISPLAY PANEL - 85g Tube Carton

    NDC 58980-605-30
    Net WT. 3 oz. (85g)

    UREA 10% CREAM

    STRATUS
    PHARMACEUTICALS INC

    Softens and Moisturizes Severe Dry Skin

    Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

    PRINCIPAL DISPLAY PANEL - 85g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    UREA 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-605
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Urea (Urea) Urea 8.5 g  in 85 g
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-605-30 1 in 1 BOX
    1 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 05/01/2010
    Labeler - Stratus Pharmaceuticals, Inc (789001641)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products, Inc 104283945 MANUFACTURE
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