Label: UREA- urea cream

  • NDC Code(s): 44523-617-01, 44523-617-03, 44523-617-07
  • Packager: BioComp Pharma, Inc.
  • 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 March 15, 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.

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  • DESCRIPTION:

    Each gram contains 400 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide and xanthan gum.


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

    structure.jpg

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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:

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

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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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  • WARNING:

    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.


    Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

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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. Keep bottle tightly closed.

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  • HOW SUPPLIED:

    1 oz. (28.35 g) bottles, NDC 44523-617-01
    3 oz. (85 g) bottles, NDC 44523-617-03
    7 oz. (198.4 g) bottles, NDC 44523-617-07

    To report a serious adverse event or obtain product information, call (866) 762-2365.

    Manufactured for:
    BIOCOMP PHARMA, INC.
    San Antonio, TX 78230 1355
    827650 R0218

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  • INGREDIENTS AND APPEARANCE
    UREA 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44523-617
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 400 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44523-617-01 1 in 1 CARTON 03/15/2018
    1 28.35 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:44523-617-03 85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2018
    3 NDC:44523-617-07 198.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/15/2018
    Labeler - BioComp Pharma, Inc. (829249718)
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