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Urea Lotion 40% | UREA [Trinity Pharmaceuticals, LLC] | BioPortfolio

13:37 EST 27th January 2019 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Rx Only

For external use only. Not for ophthalmic use.

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 inactive ingredients: Water, Propylene Glycol, Glyceryl Stearate, Mineral Oil, Cetyl Alcohol, Carbomer, Petrolatum, Xanthan Gum and Sodium Hydroxide.

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

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 the skin.

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, as well as damaged, ingrown and devitalized nails.

Known hypersensitivity to any of the listed ingredients.

For topical 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 and consult a physician.

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 40% 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 40% is administered to a nursing woman.

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

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 physician.

Urea Lotion 40% Cream 8 oz. (226.8g): NDC 54295-312-18 Store at room temperature 15°C - 30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Marketed by: Trinity Pharma LLC 2255 Glades RoadSuite 324ABoca Raton, FL 33431

Manufacturer

Trinity Pharmaceuticals, LLC

Active Ingredients

Source

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Clinical Trials [174 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.

Dialysis Weaning in Intensive Care Units (Dialysis STOP)

Evaluation of daily urinary urea excretion, to guide Renal Replacement Therapy weaning, in Intensive Care Units. The objective is to show that remove the dialysis catheter, once daily uri...

PubMed Articles [391 Associated PubMed Articles listed on BioPortfolio]

Preliminary evaluation of a salivary urea test strip method for use in dogs.

Salivary urea concentrations correlate with serum urea concentrations in dogs and humans. Salivary urea concentrations can now be determined semi-quantitatively using a salivary urea test strip method...

Noninvasive imaging of renal urea handling by CEST-MRI.

Renal function is characterized by concentration of urea for removal in urine. We tested urea as a CEST-MRI contrast agent for measurement of the concentrating capacity of distinct renal anatomical re...

Characterization of urea transport mechanisms in the intestinal tract of growing pigs.

Pigs are capable of nitrogen salvage via urea recycling, which involves the movement of urea into the gastrointestinal tract. Aquaporins (AQP) and urea transporter B (UT-B) are involved in urea-recycl...

Urea's match in the hydrogen-bond network? A high pressure THz study.

We present results of the measurement of the low frequency spectrum of solvated urea. The study revealed a blue shift of the intramolecular mode of urea centered at 150 cm of Δν= 17 cm upon incr...

A Case of Atypical Adult Presentation of Urea Cycle Disorder.

Urea cycle disorders are metabolic disorders of nitrogenous waste substances due to either complete or partial deficiency of enzymes. Hyperammonemia associated with urea cycle disorders should be addr...

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