Label: UREA- urea cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/11

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  • SPL UNCLASSIFIED SECTION

    (in a cream base)

    Rx only

    For external use only. Not for ophthalmic use.
    Keep away from eyes, lips and mucous membranes.

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  • DESCRIPTION

    DESCRIPTION: UREA CREAM 45% is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 45% Urea in a cream base of: camphor, edetate disodium, alcohol, eucalyptus oil, hydroxyethyl cellulose, menthol, purified water, titanium dioxide, sodium hydroxide.

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

    structure
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  • CLINICAL PHARMACOLOGY

    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 removal of devitalized nail plate tissue.

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  • PHARMACOKINETICS

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

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  • INDICATIONS & USAGE

    INDICATIONS AND USES: Urea 45% Cream is indicated for use in the topical treatment 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

    CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

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  • WARNINGS

    WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes. If swallowed seek medical attention or contact a Poison Control Centter immediately.

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  • PRECAUTIONS

    PRECAUTIONS: Use this medication only as directed by a physician. It should not be used to treat and condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

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  • PREGNANCY

    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, Urea Cream 45% should be given to a pregnant woman only if clearly needed.

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  • NURSING MOTHERS

    NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea Cream 45% is administered to a nursing woman.

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  • ADVERSE REACTIONS

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

    Call your doctor for medical advice about side effects.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINSTRATION: Apply Urea Cream 45% to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.

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  • HOW SUPPLIED

    HOW SUPPLIED: Urea Cream 45% is supplied in 9 oz. (255 g) tubes, NDC 42808-0202-09.

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  • STORAGE AND HANDLING

    Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). See USP Controlled Room Temperature. Protect from freezing.

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  • SPL UNCLASSIFIED SECTION

    Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

    00-0200-99-205-01

    Iss:10/11

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  • PRINCIPAL DISPLAY PANEL

    For External Use Only

    NDC 42808-0202-09        Rx Only

    Urea
    In a vehicle containing
    camphor, eucalyptus oil
    and menthol

    45%

    CREAM

    Exact-Rx.
    INCORPORATED

    Net Wt. 9 oz (255 g)

    Carton

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  • INGREDIENTS AND APPEARANCE
    UREA 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42808-202
    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  
    ALCOHOL  
    EUCALYPTUS OIL  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
    MENTHOL  
    WATER  
    TITANIUM DIOXIDE  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42808-202-09 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 08/01/2011
    Labeler - Exact-Rx, Inc. (137953498)
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