Advertisement

Topics

Urea 47% Cream | Urea 47% Cream [Rosemar Labs, LLC] | BioPortfolio

12:58 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.

Each gram contains 470 mg of urea in a vehicle consisting of: camphor, disodium EDTA, eucalyptus oil, hydroxyethyl cellulose, menthol, purified water, SD alcohol 40B 200 proof, and titanium dioxide.

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

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 of the skin.

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

This product is a keratolytic emollient useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

WARNING: KEEP OUT OF THE REACH OF CHILDREN.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

General: This product 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.

Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.

Pregnancy: Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

NOTICE: Protect from freezing and excessive heat.

Keep bottle tightly closed.

5 oz. (142 g) bottles, NDC 50096-501-05

To report a serious adverse event or obtain product information, call 1-855-899-4237.

Manufactured for: Bowyn Labs, LLC 13785 Research Blvd., Suite 125 Austin, TX 78750 1800074 v1 Rev. 08/2018

Manufacturer

Rosemar Labs, LLC

Active Ingredients

Source

Drugs and Medications [921 Associated Drugs and Medications listed on BioPortfolio]

Dermasorb xm complete kit [crown laboratories]

DERMASORB XM COMPLETE KIT

Urea [austin pharmaceuticals, llc]

Urea Cream 39%

Urea [trinity pharmaceuticals, llc]

Urea Cream 39%

Ure-k [solutech pharmaceuticals llc]

URE-K 50%(Urea 50% in a cream base)

Rynoderm [solutech pharmaceuticals llc]

RYNODERM CREAM(Urea 37.5% in a cream base)

Clinical Trials [758 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 [483 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...

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...


Drugs and Medication Quicklinks


Searches Linking to this Drug Record