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UREA (ACELLA PHARMACEUTICALS)

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EMULSION 283.5 g in 1 TUBE (42192-101-10) Label Information

Complete UREA Information

  • DESCRIPTION

    DESCRIPTION: Each gram of 50% Urea Emulsion contains 50% urea in a formulation consisting of: caprylic/capric triglyceride, cetyl alcohol, disodium EDTA, glycerin, hydroxyethyl cellulose, lactic acid, linoleic acid, PEG-6, polysorbate 60, propylene glycol, sorbitan stearate, titanium dioxide, triethanolamine, purified water, vitamin E, xanthan gum and zinc undecylenate.

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

    urea chemical formula


  • CLINICAL PHARMACOLOGY

    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.


  • PHARMACOKINETICS

    PHARMACOKINETICS: The mechanism of action of the topically applied Urea is not yet known.


  • INDICATIONS & USAGE

    INDICATIONS AND USAGE: 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.


  • CONTRAINDICATIONS

    CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.


  • WARNINGS

    WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes.


  • PRECAUTIONS

    PRECAUTIONS: This medication 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.


  • PREGNANCY

    PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, 50% Urea Emulsion should be given to a pregnant woman only if clearly needed.


  • NURSING MOTHERS

    NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Urea Emulsion is administered to a nursing woman


  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.


  • ADVERSE REACTIONS

    ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.


  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Apply 50% Urea Emulsion to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.


  • HOW SUPPLIED

    HOW SUPPLIED: 50% Urea Emulsion is supplied in a 10 oz. tube (NDC 42192-101-10). Store at controlled room temperature, 15° - 30° (59° - 86°F). Protect from freezing.


  • DESCRIPTION

    All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, incipients, inactive ingredients and chemical formulation information provided herein.

    MANUFACTURED FOR: Acella Pharmaceuticals, LLC
    9005 Westside Parkway
    Alpharetta, GA 30009
    1-800-541-4802


  • DOSAGE & ADMINISTRATION

    How to properly use

    50% Urea

    Emulsion

    In a zinc undecylenate and lactic acid vehicle



    Easy steps to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris,

    keratoderma, dermatitis, pruritus, eczema, corns and calluses.



    For skin:

    1. Apply 50% Urea Emulsion to affected skin twice per day, or as directed by a physician.

    2. Rub in until completely absorbed (for best results apply to moistened skin).


  • PRINCIPAL DISPLAY PANEL

    NDC 42192-101-10

    50% Urea
    Emulsion
    In a zinc undecylenate and lactic acid vehicle

    Rx Only
    Net Weight 10 oz
    For Topical Use Only

    Indications: For use on rough dry skin
    conditions. See carton or package insert for
    instructions.

    USE ONLY AS DIRECTED BY A
    PHYSICIAN.

    Ingredients: Each gram of 50% Urea
    Emulsion contains 50% urea in a formulation
    consisting of caprylic or capric triglyceride,
    cetyl alcohol, disodium EDTA, glycerin,
    hydroxyethyl cellulose, lactic acid, linoleic
    acid, PEG-6, polysorbate 60, propylene
    glycol, sorbitan stearate, titanium dioxide,
    triethanolamine, purified water, vitamin E,
    xanthan gum and zinc undecylenate.

    KEEP THIS AND ALL MEDICATIONS OUT
    OF THE REACH OF CHILDREN.
    FOR EXTERNAL USE ONLY.
    NOT FOR OPHTHALMIC USE.

    Storage: Store at controlled room temperature
    15 - 30C (59 - 86F) Protect from
    freezing.

    For lot number and expiration date, see
    crimp of tube.

    All prescription substitutions using this
    product shall be made subject to state and
    federal statutes as applicable. Note: This is
    not an Orange Book product. Please see
    insert for further details.

    Manufactured for:
    Acella Pharmaceuticals
    9005 Westside Parkway
    Alpharetta, GA 30009
    1-800-541-4802


  • INGREDIENTS AND APPEARANCE
    UREA 
    urea emulsion
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 50 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    TRICAPRIN (UNII: O1PB8EU98M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINC UNDECYLENATE (UNII: 388VZ25DUR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42192-101-10 283.5 g in 1 TUBE; Type 0: Not a Combination Product 06/29/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/29/2009
    Labeler - ACELLA PHARMACEUTICALS (825380939)