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Urea (Libertas Pharma, Inc.)

Available Formats

Dosage Form Package Information Links
GEL 1 BOTTLE, GLASS in 1 CARTON (51862-181-28) > 28 g in 1 BOTTLE, GLASS Label Information

Complete Urea Information

  • SPL UNCLASSIFIED SECTION

    FOR TOPICAL USE ONLY

    28 mL Bottle
    with Applicator Brush


  • Directions:

    Apply LIBERTAS PHARMA INC.'s 45% UREA NAIL GEL to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.


  • WARNINGS

    FOR EXTERNAL USE ONLY.
    NOT FOR OPHTHALMIC USE.


  • PRECAUTIONS

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. If swallowed seek medical attention or contact a Poison Control Center immediately.

    USE ONLY AS DIRECTED BY A PHYSICIAN.

    CAUTION: If redness or irritation occurs, discontinue use. Avoid contact with eyes.


  • Ingredients:

    Each gram of Libertas Pharma Inc.'s 45% Urea Nail Gel contains 45% Urea. Other ingredients include: Camphor, Disodium EDTA, Eucalyptus Oil, Hydroxyethylcellulose, Menthol, Propylene Glycol, and Purified Water.

    PLEASE SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.

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

    Manufactured for:
    Libertas Pharma Inc.
    Lawrenceville, GA 30043

    Rev. 7/11   181-28


  • PRINCIPAL DISPLAY PANEL

    NDC 51862-181-28

    Rx Only

    45% Urea Nail Gel

    In a vehicle containing Camphor, Eucalyptus Oil and Menthol

    FOR TOPICAL USE ONLY

    28 mL Bottle
    with Applicator Brush

    Libertas Pharma, Inc.

    Carton


  • INGREDIENTS AND APPEARANCE
    UREA 
    urea gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-181
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 450 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51862-181-28 1 in 1 CARTON 10/28/2011 03/31/2019
    1 28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 10/28/2011 03/31/2019
    Labeler - Mayne Pharma Inc. (867220261)