Label: UREA 40 PERCENT- urea cream

  • NDC Code(s): 58657-487-01, 58657-487-03, 58657-487-07
  • Packager: Method Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 12, 2023

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  • DESCRIPTION:

    INGREDIENTS: Each gram

    of Urea Cream 40%

    contains Urea 40% and the

    following inactive

    ingredients: Carbomer,

    Cetearyl Alcohol, Glycerin,

    Glyceryl Stearate SE,

    Mineral Oil, Purified Water,

    White Petrolatum.

    structure

  • 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 of the skin.

    Pharmacokinetics:

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

  • INDICATIONS:

    This product 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.

  • CONTRAINDICATIONS:

    This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

  • WARNINGS:

    FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.

    Avoid contact with eyes, lips and mucous membranes.

    General:

    This product 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.

    Information for Patients:

    Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

    Carcinogenesis, Mutagenesis and Impairment of Fertility:

    Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.

    Pregnancy:

    Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

    Nursing Mothers:

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

  • ADVERSE REACTIONS:

    Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

  • DOSAGE AND ADMINISTRATION:

    Use as
    directed by your physician.
    See label booklet for full
    Prescribing Information.

  • STORAGE:

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

  • HOW SUPPLIED:

    This product is supplied in the following size(s): 3 oz, 1 oz, and 7oz

    To report a serious adverse event or obtain product information, call 877-250-3427

    To report a serious adverse event, please contact Method Pharmaceuticals at (877) 250-3427; email at contact@methodpharm.com; or call FDA at (800) FDA-1088.

    Manufactured for:

    Method Pharmaceuticals, LLC Fort Worth, Texas 76118

    Rev. 11/21

  • PRINCIPAL DISPLAY PANEL

    137

  • INGREDIENTS AND APPEARANCE
    UREA 40 PERCENT 
    urea cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58657-487
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-487-07198.4 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2021
    2NDC:58657-487-0128.35 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2021
    3NDC:58657-487-0385 g in 1 BOTTLE; Type 0: Not a Combination Product11/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/15/2021
    Labeler - Method Pharmaceuticals, LLC (060216698)
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