Label: UREA- urea cream

  • NDC Code(s): 42291-849-19, 42291-849-28, 42291-849-85
  • Packager: AvKARE, 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 September 28, 2018

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

  • DESCRIPTION

    Rx Only

    For external use only. Not for ophthalmic use.

    Description

    Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40%contains 40% urea as an active ingredient, and the following inactive ingredients: Ceteareth-6, Ceteareth-25, Cetyl Alcohol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Hydroxide, Stearyl Alcohol, 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 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

    The mechanism of action of topically applied urea is not yet known.

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  • 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, as well as damaged, ingrown and devitalized nails.

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  • Contraindications

    Known hypersensitivity to any of the listed ingredients.

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  • Warnings

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

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  • 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 and consult a physician.

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  • 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 reproductive studies are not always predictive of human response, Urea 40% should be given to a pregnant woman only if clearly needed.

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  • 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 Urea 40% 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 medication.

    To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email
    drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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  • Dosage and Administration

    Apply Urea 40% to affected skin twice per day, or as directed by your 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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  • How Supplied

    Urea 40% Cream

    1 oz. (28.35 g): NDC 42291-849-28


    Urea 40% Cream

    3 oz. (85 g): NDC 42291-849-85


    Urea 40% Cream

    7 oz. (198.4 g): NDC 42291-849-19


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

    Protect from freezing. Keep bottle tightly closed.



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



    Manufactured for:
    AvKARE, Inc.
    Pulaski, TN 38478

    AV Rev. 09/18 (P) Rev. 09/18

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  • Tube Label
  • Carton
  • INGREDIENTS AND APPEARANCE
    UREA 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-849
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 40 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42291-849-28 1 in 1 CARTON 11/06/2017
    1 28 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:42291-849-85 1 in 1 CARTON 11/06/2017
    2 85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:42291-849-19 1 in 1 CARTON 11/06/2017
    3 198 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/06/2017
    Labeler - AvKARE, Inc. (796560394)
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