Label: UREA CREAM 40%- urea cream

  • NDC Code(s): 16477-340-01, 16477-340-03, 16477-340-07
  • Packager: Laser Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 11, 2024

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  • WARNINGS AND PRECAUTIONS
    Urea Cream 40% Rx Only For external use only. Not for ophthalmic use.
  • Description
    Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% urea as an active ingredient, and the following ...
  • Clinical Pharmacology
    Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of ...
  • Pharmacokinetics
    The mechanism of action of topically applied urea is not yet known.
  • Indications and 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 ...
  • Contraindications
    Known hypersensitivity to any of the listed ingredients.
  • Warnings
    For topical use only.  Avoid contact with eyes, lips or mucous membranes.
  • 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 ...
  • PREGNANACY
    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 ...
  • 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 40% is administered to a nursing ...
  • Adverse Reactions
    Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.
  • Dosage and Administration
    Apply Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a ...
  • How Supplied
    Urea 40% Cream 1 oz.(28.35 g): NDC 16477-340-01; Urea 40% Cream 3 oz.(85 g): NDC 16477-340-03; Urea 40% Cream 7 oz.(198.4 g): NDC 16477-340-07 Store at room temperature 15°C - 30°C (59°F - 86°F) ...
  • KEEP OUT OF REACH OF CHILDREN
    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • SPL UNCLASSIFIED SECTION
    Marketed by: Laser Pharmaceuticals, LLC - 1015 Nine North Drive, Sutie 400 - Alpharetta, GA 30004 - 1-844-302-5227
  • PRINCIPAL DISPLAY PANEL
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  • INGREDIENTS AND APPEARANCE
    Product Information