Label: X VIATE- urea cream 

  • NDC Code(s): 58980-625-10, 58980-625-30, 58980-625-70
  • Packager: Stratus Pharamceuticals, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 10/10

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

  • SPL UNCLASSIFIED SECTION

    Rx only

    For external use only.
    Not for ophthalmic use.

    Close
  • DESCRIPTION

    X-VIATE™ is a potent keratolytic emollient which is a gentle tissue softener for skin and/or nails.

    Each gram of X-VIATE™ 40% CREAM contains 40% Urea in a cream base of Carbopol, Cetyl Alcohol, Glyceryl Monostearate, Light Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, White Petrolatum and Xanthan Gum.

    Each gram of X-VIATE™ 40% LOTION contains 40% Urea in a lotion base of Carbopol, Cetyl Alcohol, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Propyl Paraben, Propylene Glycol, Purified Water, Trolamine, White Petrolatum and Xanthan Gum.

    Each gram of X-VIATE™ 40% GEL contains 40% Urea in a gel base of Hydroxyethyl Cellulose, Methyl Paraben, Propylene Glycol and Purified Water.

    CHEMISTRY

    Urea is a diamide of carbonic acid with the following chemical structure:

    Chemical Structure
    Close
  • 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.

    Close
  • 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.

    Close
  • CONTRAINDICATIONS

    Known hypersensitivity to any of the listed ingredients.

    Close
  • WARNINGS

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

    Close
  • 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, X-VIATE™ 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 X-VIATE™ is administered to a nursing woman

    Close
  • ADVERSE REACTIONS

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

    Close
  • DOSAGE AND ADMINISTRATION

    Apply X-VIATE™ 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.

    Close
  • HOW SUPPLIED

    X-VIATE™ 40% CREAM (40% Urea) is supplied in:

    28.5g (1 oz) tube 58980-625-10
    85g (3 oz) tube 58980-625-30
    199g (7 oz) tube 58980-625-70

    X-VIATE™ 40% LOTION (40% Urea) is supplied in:

    237mL (8 oz) bottle 58980-623-80

    X-VIATE™ 40% GEL (40% Urea) is supplied in:

    15mL bottle 58980-624-15

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

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Stratus Pharmaceuticals Inc,
    Miami, Florida 33186-6727
    Tollfree: 800-442-7882
    www.stratuspharmaceuticals.com

    Manufactured by:
    Sonar Products, Inc., Carlstadt, NJ 07072

    PG-XVG-IN 2009-0608

    Close
  • PRINCIPAL DISPLAY PANEL - 199g Tube Carton

    X-VIATE 40% CREAM

    NDC 58980-625-70

    X-VIATE™

    40%
    CREAM

    Softens and
    Moisturizes
    Severe
    Dry
    Skin

    Rx only

    UREA 40%
    IN A CREAM BASE

    Distributed by:
    STRATUS
    PHARMACEUTICALS INC

    NET WT 7 oz (199g)

    PRINCIPAL DISPLAY PANEL - 199g Tube Carton
    Close
  • INGREDIENTS AND APPEARANCE
    X VIATE 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-625
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Urea (Urea) Urea 0.4 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Cetyl Alcohol  
    Glyceryl Monostearate  
    Light Mineral Oil  
    Propylene Glycol  
    Water  
    Sodium Hydroxide  
    Petrolatum  
    Xanthan Gum  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-625-10 1 in 1 BOX
    1 28.3 g in 1 TUBE
    2 NDC:58980-625-30 1 in 1 BOX
    2 85 g in 1 TUBE
    3 NDC:58980-625-70 1 in 1 BOX
    3 199 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 04/11/2005
    Labeler - Stratus Pharamceuticals, Inc (789001641)
    Registrant - Sonar Products, Inc (104283945)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products, Inc 104283945 MANUFACTURE
    Close