Label: UREA 47% CREAM- urea cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated December 13, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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, 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:

    structure.jpg

  • 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 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.

  • CONTRAINDICATIONS:

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

  • WARNINGS

    WARNING: KEEP OUT OF THE REACH OF CHILDREN.

  • PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

    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.

  • DOSAGE AND ADMINISTRATION:

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

  • STORAGE:

    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.

  • HOW SUPPLIED:

    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

  • PRINCIPAL DISPLAY PANEL

    label.jpg

  • INGREDIENTS AND APPEARANCE
    UREA 47% CREAM 
    urea cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50096-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA470 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50096-501-05142 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2011
    Labeler - Rosemar Labs, LLC (078461488)