Label: UREA- 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 April 12, 2018

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

  • DESCRIPTION:

    Each gram contains 410 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, glyceryl stearate, mineral oil, petrolatum, propylene glycol, sodium hydroxide, water and xanthan gum.

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

    structure

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  • 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.

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  • INDICATIONS:

    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.

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  • CONTRAINDICATIONS:

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

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  • WARNINGS:

    KEEP OUT OF REACH OF CHILDREN.

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  • 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.

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  • ADVERSE REACTIONS:

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

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  • DOSAGE AND ADMINISTRATION:

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

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  • 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. The product may tend to darken in color on storage. The discoloration does not impair the efficacy or safety of the product. Keep bottle tightly closed.

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  • HOW SUPPLIED:

    This product is supplied in the following size(s):

    8 oz. (227 g) bottles, NDC 52191-351-08

    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

    828003 v1 Rev. 04/2018

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  • INGREDIENTS AND APPEARANCE
    UREA 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52191-351
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 410 mg  in 1 g
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52191-351-08 227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/12/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/12/2018
    Labeler - Bowyn Labs, LLC (078521752)
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