Label: CEM-UREA - urea solution

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 16, 2011

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  • DESCRIPTION

    CEM-UreaTM (45% Urea) is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of CEM-UreaTM (45% Urea) contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, methyl paraben, propylene glycol and purified water.
    Urea is a diamide of carbonic acid with the following 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. Close
  • PHARMACOKINETICS

    The mechanism of action of topically applied Urea is not yet known. Close
  • INDICATIONS & USAGE

    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 AND PRECAUTIONS

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

    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.

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  • 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, CEM-UreaTM (45% Urea) should be given to a pregnant woman only if clearly needed.

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  • 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 CEM-UreaTM (45% Urea) 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 & ADMINISTRATION

    DIRECTIONS FOR NAILS: Apply CEM-UreaTM (45% Urea) to diseased or damaged nail tissue twice per day, or as directed by a physician.

    DIRECTIONS FOR SKIN: Apply CEM-UreaTM (45% Urea) to affected area(s) twice per day, or as directed by a physician.

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  • HOW SUPPLIED

    CEM-UreaTM (45% Urea) 20 mL tube, NDC 42546-100-20

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  • STORAGE AND HANDLING

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

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  • PRINCIPAL DISPLAY PANEL

    NDC 42546-100-20

    CEM-Urea Pre-Filled Applicator 45% urea

    In a vehicle containing Menthol, Camphor, and Eucalyptus Oil

    Rx only

    0.68 FL OZ (20 mL)

    PruGen, Inc. Pharmaceuticals

    image of tube label



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  • INGREDIENTS AND APPEARANCE
    CEM-UREA 
    urea solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42546-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA .45 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42546-100-20 1 in 1 BOX
    1 20 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/01/2011
    Labeler - PruGen, Inc. (929922750)
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