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Urea 47% Cream

Pronunciation

Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Urea 47% Cream

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DESCRIPTION:

Each gram contains 470 mg of urea in a vehicle consisting of: camphor, disodium EDTA, alcohol SDA 40, eucalyptus oil, hydroxyethylcellulose, menthol, water and titanium dioxide.

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

CLINICAL PHARMACOLOGY:

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.

INDICATIONS AND USAGE:

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

CONTRAINDICATIONS:

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

WARNINGS: KEEP OUT OF REACH OF CHILDREN.

PRECAUTIONS: 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.

ADVERSE REACTIONS:

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. To report a serious adverse event, call 1-855-899-4237.

DOSAGE AND ADMINISTRATION:

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

HOW SUPPLIED:

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

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.

Protect from freezing and excessive heat. Keep bottle tightly closed.

Urea 47% Cream 
urea cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50096-501
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 470 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (NATURAL)  
EDETATE DISODIUM  
ALCOHOL  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)  
MENTHOL  
WATER  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:50096-501-05 142 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/01/2011
Labeler - Rosemar Labs, LLC (078461488)
Revised: 11/2014
 
Rosemar Labs, LLC



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