Label: UREA CREAM 40%- urea cream

  • NDC Code(s): 16477-340-01, 16477-340-03, 16477-340-07
  • Packager: Laser Pharmaceuticals, LLC
  • 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 December 3, 2018

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

  • WARNINGS AND PRECAUTIONS

    Urea Cream 40%

    Rx Only     For external use only.     Not for ophthalmic use.

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  • DESCRIPTION

    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:  Carbomer, Dimethyl Isosorbide, Emulsifying Wax, Glycerin, Isopropyl Myristate, Neopentyl Glycol Dicaprylate/Dicaprate, Purified Water, Sodium Hydroxide, Tridecyl Stearate, Tridecyl Trimellilate, and Xanthan Gum.

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

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  • CLINICAL PHARMACOLOGY

    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

    Pharmacokinetics

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

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  • INDICATIONS & USAGE

    Indications and Usage

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

    Contraindications

    Known hypersensitivity to any of the listed ingredients.

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  • WARNINGS

    Warnings

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

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  • 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 and consult a physician.

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  • PREGNANCY

    PREGNANACY

    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

    Adverse Reactions

    Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.

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  • DOSAGE & ADMINISTRATION

    Dosage and Administration

    Apply Urea 40% to affected skin twice a 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.

    All prescription substitutions and/or recommendations 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.  No representation is made as to generic status or bioequivalency.  Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluation of the active ingredients, excipients, inactive ingredients and chemical information provided herein.

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  • HOW SUPPLIED

    How Supplied

    Urea 40% Cream 1 oz.(28.35 g):  NDC 16477-340-01; Urea 40% Cream 3 oz.(85 g):  NDC 16477-340-03; Urea 40% Cream 7 oz.(198.4 g):  NDC 16477-340-07

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  • STORAGE AND HANDLING

    Store at room temperature 15 οC - 30 οC (59 οF - 86 ο F).  Protect from freezing.  Keep bottle tightly closed.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INGREDIENTS AND APPEARANCE
    UREA CREAM 40% 
    urea cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16477-340
    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
    ISOSORBIDE (UNII: WXR179L51S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16477-340-03 85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2018
    2 NDC:16477-340-07 198.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2018
    3 NDC:16477-340-01 28.35 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/04/2018
    Labeler - Laser Pharmaceuticals, LLC (614417132)
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