04:53 EDT 27th August 2014 | BioPortfolio
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In a lactic acid & salicylic acid vehicle

Rx only

For external use only. Not for ophthalmic use.

Each gram of Urea Topical Suspension contains 50% urea in a formulation consisting of caprylic/capric triglyceride, carbomer, cetyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, lactic acid, linoleic acid, PEQ-6, polysorbate 60, propylene glycol, purified water, salicylic acid, sorbitan stearate, titanium dioxide, triethanolamine, vitamin E and xanthan gum.

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

IMAGE urea-top-sus-50-01.jpg

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.

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

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 pilaris, keratosis palmaris, keratoderma, corns and calluses.

Known hypersensitivity to any of the listed ingredients.

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.

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, Urea Topical Suspension should be given to a pregnant woman only if clearly needed.

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 Topical Suspension is administered to a nursing woman.


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

Apply Urea Topical Suspension to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

Urea Topical Suspension 50% is supplied as:

284 g (10 oz) tube, NDC 0168-0493-84

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

Protect from freezing.

Manufactured for: E. F0UGERA & CO.A division of Nycomed US Inc.Melville, New York 11747

Manufactured by: Pegasus Laboratories, Inc.Pensacola, FL 32514



How to properly usefouqera UREA TOPICAL SUSPENSION 50% In a lactic acid & salicylic acid vehicle

Rx only

Steps to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, eczema, corns and calluses.

For skin:

See other side for full prescribing information.

NDC 0168-0493-84



In a lactic acid &salicylic acid vehicle

For Topical Use Only

Rx only

Net Wt. 10 oz (284 g)

E. FOUGERA & CO.A division of Nycomed US Inc.Melville, New York 11747

IMAGE urea-top-sus-50-02.jpg

NDC 0168-0493-84



In a lactic acid &salicylic acid vehicle

For Topical Use Only

Rx only

Net Wt. 10 oz (284 g)

E. FOUGERA & CO.A division of Nycomed US Inc.Melville, New York 11747

IMAGE urea-top-sus-50-03.jpg


E. FOUGERA & CO., A division of Nycomed US Inc.

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Clinical Trials [117 Associated Clinical Trials listed on BioPortfolio]

Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment

In this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for p...

Study of Treatment and Metabolism in Patients With Urea Cycle Disorders

RATIONALE: The urea cycle is the process in which nitrogen is removed from the blood and converted into urea, a waste product found in urine . Urea cycle disorders are inherited disorders ...

Urease Inhibitor Drug Treatment for Urea Cycle Disorders

The purpose of this study is to determine if acetohydroxamic acid (AHA) can prevent hydrolysis of urea by inhibiting the bacterial urease of gut flora of both healthy control adults as wel...

Dose-Escalation Safety Study of HPN-100 to Treat Urea Cycle Disorders

The purpose of this study is to determine whether HPN-100 is safe and tolerable in subjects with Urea Cycle Disorders.

The Influence of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Disease

The purpose of this study is to investigate if wearing of compression stockings influences the skin moisture. Conservative stockings are compared with urea containing compression stockings...

PubMed Articles [412 Associated PubMed Articles listed on BioPortfolio]

Utilization of urea and expression profiles of related genes in the dinoflagellate Prorocentrum donghaiense.

Urea has been shown to contribute more than half of total nitrogen (N) required by phytoplankton in some estuaries and coastal waters and to provide a substantial portion of the N demand for many harm...

Impact of Intradialytic Exercise Intensity on Urea Clearance in Hemodialysis Patients.

Intradialytic exercise (IDE) has been shown to benefit dialysis efficacy; however, the effect of IDE intensity is unknown. Dialyzer urea clearance (K urea, ml/min) was significantly greater during bot...

Modulation of cadmium-induced phytotoxicity in Cabomba caroliniana by urea involves photosynthetic metabolism and antioxidant status.

Urea is a widespread organic pollutant, which can be a nitrogen source, playing different roles in the growth of submerged macrophytes depending on concentrations, while high cadmium (Cd) concentratio...

Urea Release by Intermittently Saturated Sediments from a Coastal Agricultural Landscape.

Urea-N is linked to harmful algal blooms in lakes and estuaries, and urea-N-based fertilizers have been implicated as a source. However, the export of urea-N-based fertilizers appears unlikely, as hig...

Molecular origin of urea driven hydrophobic polymer collapse and unfolding depending on side chain chemistry.

Osmolytes affect hydrophobic collapse and protein folding equilibria. The underlying mechanisms are, however, not well understood. We report large-scale conformational sampling of two hydrophobic poly...

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