Urea Cream 41% | Urea Cream 41% [Laser Pharmaceuticals, LLC] | BioPortfolio

13:08 EST 27th January 2019 | BioPortfolio

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Urea Cream 41%

Rx Only     For external use only.     Not for ophthalmic use.


Urea 41% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin.  Each gram of Urea 41% contains 41% urea as an active ingredient, and the following inactive ingredients:  Carbomer, Dimethyl Isosorbide, Emulsifying Wax, Glycerin, Isopropyl Myristate, Neopentyl Glycol Dicaprylate/Dicaprate, Purified Water, Sodium Hydroxide, Tridecyl Stearate, Tridecyl Trimellitate, and Xanthan Gum.

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

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 the skin.


The mechanism of action of topically applied urea is not yet known.

Indications and Usage

For debridement and promotion of healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar.  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.

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 reproductive studies are not always predictive of human response, Urea 41% 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 41% is administered to a nursing woman.

Adverse Reactions

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

Dosage and Administration

Apply Urea 41% to affected skin twice a 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.

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.  Please note:  this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing.  No representation is made as to generic status or bioequivalency.  Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

How Supplied

Urea 41% Cream 8 oz.(227 g):  NDC 16477-341-08

Store at room temperature 15 C - 30 C (59 F - 86 F).  Protect from freezing.  Keep bottle tightly closed.



Laser Pharmaceuticals, LLC

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Clinical Trials [756 Associated Clinical Trials listed on BioPortfolio]

Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%

The main objective of this study is to compare subject adherence and satisfaction for two modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and a...

Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste

The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste.

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine w...

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...

Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-Propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound

to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream

PubMed Articles [478 Associated PubMed Articles listed on BioPortfolio]

Recent Advances in the Electro-Oxidation of Urea for Direct Urea Fuel Cell and Urea Electrolysis.

This paper provides an overview of recent advances in urea electro-oxidation. Urea sources are abundant from human urine, urea-containing wastewater, and industrial urea, thus becoming an attractive o...

Noncovalent Interactions between Tri-Methylamine N-Oxide (TMAO), Urea, and Water.

Trimethylamine N-Oxide (TMAO) and urea are two important osmolytes with their main significance to the biophysical field being in how they uniquely interact with proteins. Urea is a strong protein des...

Flow behavior, viscoelastic, textural and foaming characterization of whipped cream: Influence of Lallemantia royleana seed, Salvia macrosiphon seed and carrageenan gums.

The effects of sage (Salvia macrosiphon) seed gum (SSG), balangu (Lallemantia royleana) seed gum (BSG) and carrageenan gum were examined on the foaming qualities (foam stability, foam capacity and ove...

Fludroxycortide cream as an alternative therapy for actinic cheilitis.

The objective of the study is to assess, by clinical follow-up, the efficacy of the dermatological cream Fludroxycortide 0.125 mg/g (Drenison®) in the treatment of actinic cheilitis (AC).

Significant therapeutic response to cysteamine cream in a melasma patient resistant to Kligman's formula.

L-Cysteamine is a biological antioxidant produced during the coenzyme A metabolism cycle and is naturally present in all mammalian cells. The efficacy of topical cysteamine for the treatment of melasm...

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