Label: URAMAXIN- urea cream 

  • Label RSS
  • NDC Code(s): 43538-210-09
  • Packager: Medimetriks Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 03/11

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

  • SPL UNCLASSIFIED SECTION

    Rx Only

    In a vehicle containing Menthol, Camphor and Eucalyptus Oil

    For external use only. Not for ophthalmic use.

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  • DESCRIPTION

    Uramaxin® (45% Urea) Cream is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Uramaxin® (45% Urea) Cream contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water.

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

    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 purulent 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, devitalized and ingrown 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

    This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

    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 reproductive studies are not always predictive of human response, Uramaxin® (45% Urea) 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 Uramaxin® (45% Urea) Cream is administered to a nursing woman.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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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 Uramaxin® (45% Urea) Cream to affected skin twice per day, or as directed by a physician. Apply to diseased or damaged nails twice per day, or as directed by a physician.

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  • HOW SUPPLIED

    Uramaxin® (45% Urea) Cream
    9 oz. tube, NDC 43538-210-09

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

    Protect from freezing.

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    363 Route 46 West
    Fairfield, NJ 07004-2402 USA

    www.medimetriks.com

    Manufactured by:
    Groupe PARIMA, Inc.
    Montreal, QC H4S 1X6 CANADA

    IP002-R1
    Iss. 7/09

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  • PRINCIPAL DISPLAY PANEL - 255 g Carton

    NDC 43538-210-09

    Rx Only
    Uramaxin®
    (45% UREA) CREAM

    In a vehicle containing
    Menthol, Camphor
    and Eucalyptus Oil

    FOR TOPICAL USE ONLY

    Net Wt. 9 oz (255 g)

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    PRINCIPAL DISPLAY PANEL - 255 g Carton
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  • INGREDIENTS AND APPEARANCE
    URAMAXIN 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-210
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    urea (urea) urea 450 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    camphor (synthetic)  
    edetate disodium  
    eucalyptus oil  
    menthol  
    propylene glycol  
    water  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43538-210-09 1 in 1 CARTON
    1 255 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/01/2009
    Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
    Establishment
    Name Address ID/FEI Business Operations
    Groupe Parima 252437850 MANUFACTURE
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