Label: UREA - urea cream UREA - urea lotion 

  • Label RSS
  • NDC Code(s): 67877-272-03, 67877-272-07, 67877-272-21, 67877-273-12
  • Packager: Ascend Laboratories, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 03/12

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

  • SPL UNCLASSIFIED SECTION


    UreaHeader

    RX ONLY

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  • DESCRIPTION

    DESCRIPTION
    Urea cream, 40% is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin.

    Each gram contains 40% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax NF, glycerin 99.7% USP, isopropyl myristate, purified water, sorbitol 70% Solution USP, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate.

    CHEMICAL STRUCTURE
    Urea is diamide of Carbonic acid with the following structure:

    ChemicalStructure

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  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY
    Urea cream gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.

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  • PHARMACOKINETICS

    PHARMACOKINETICS
    The exact mechanism of action of topically applied urea is not known.

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  • INDICATIONS & USAGE

    INDICATION AND USAGE
    Urea 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

    CONTRAINDICATIONS
    Known hypersensitivity to any of the listed ingredients

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  • WARNINGS

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

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  • PRECAUTIONS

    PRECAUTIONS
    Urea cream should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use.

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  • PREGNANCY

    Pregnancy: Category C
    Animal reproduction studies have not been conducted with Urea Cream. It is also not known whether urea cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Urea cream should be given to a pregnant woman only if clearly needed.

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  • NURSING MOTHERS

    Nursing Mothers
    It is not known whether urea cream is excreted in human milk, therefore caution should be exercised when administering to a nursing mother.

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  • ADVERSE REACTIONS

    ADVERSE REACTIONS
    Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATIONS
    Apply to affected skin twice per day, or as directeded by your physician. Rub in until completely absorbed.

    KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN

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  • HOW SUPPLIED

    HOW SUPPLIED
    Urea 40% cream is supplied in
    28.35gm               NDC 67877-272-21
    85.05gm               NDC 67877-272-03
    198.6gm               NDC 67877-272-07

    Urea 40% lotion is supplied in
    236.6ml               NDC 67877-273-12

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

    Manufactured for:                                           Manufactured by:
    Ascend Laboratories, LLC                  Crown Laboratories, Inc
    Montvale, NJ 07645                                       Johnson City, TN 37604


    P1827.01


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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - Urea Cream 40%

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    Laboratories, LLC

    NDC 67877-272-21

    Urea
    Cream
    40%


    For Topical Use
    Only

    Rx Only

    NET WT 1 oz
    (28.35g)

    CreamProductLabel


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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - Urea Lotion 40%

    ASCEND
    Laboratories, LLC

    NDC 67877-273-12

    Urea
    Lotion
    40%

    For Topical Use
    Only

    Rx Only

    8 fl oz
    (236.6ml)

    LotionProductLabel
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  • INGREDIENTS AND APPEARANCE
    UREA 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67877-272
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Urea (Urea) Urea 400 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHYL ISOSORBIDE  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    WATER  
    SORBITOL 700 mg  in 1 g
    TRIDECYL STEARATE  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE  
    TRIDECYL TRIMELLITATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67877-272-21 28.35 g in 1 TUBE
    2 NDC:67877-272-03 85.05 g in 1 TUBE
    3 NDC:67877-272-07 198.6 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/16/2012
    UREA 
    urea lotion
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67877-273
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Urea (Urea) Urea 400 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHYL ISOSORBIDE  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    WATER  
    SORBITOL 700 mg  in 1 mL
    TRIDECYL STEARATE  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE  
    TRIDECYL TRIMELLITATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67877-273-12 236.6 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/16/2012
    Labeler - Ascend Laboratories, LLC (141250469)
    Establishment
    Name Address ID/FEI Business Operations
    Crown Laboratories, Inc. 079035945 manufacture
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