Label: UREA 40%- urea cream

  • NDC Code(s): 39328-019-01, 39328-019-03, 39328-019-07
  • Packager: Patrin Pharma, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 21, 2025

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

  • DESCRIPTION

    Each gram contains 400 mg of urea in a vehicle of carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide, and xanthan gum.

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

    Chemical 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

    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.

  • CONTRAINDICATIONS

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

  • WARNING

    KEEP OUT OF REACH OF CHILDREN.

  • PRECAUTIONS

    FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

    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. 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 will normally disappear upon discontinuing the use of this product.

  • DOSAGE AND ADMINISTRATION

    Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.

    Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

  • STORAGE

    Store at 20–25°C (68–77ºF), excursions permitted to 15–30ºC (59–86ºF). Protect from freezing and excessive heat. Keep bottle tightly closed

  • HOW SUPPLIED

    28.35 g (1 oz.) bottles, NDC 39328-019-01

    85 g (3 oz.) bottles, NDC 39328-019-03

    198.4 g (7 oz.) bottles, NDC 39328-019-07

  • SPL UNCLASSIFIED SECTION

    To report SUSPECTED ADVERSE REACTIONS, contact Patrin Pharma at 1-800-936-3088 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch for voluntary reporting of suspected adverse reactions.

    Made in the USA
    Manufactured for:
    Patrin Pharma
    Skokie, IL 60076
    Questions (800) 936 3088

    Rev 01.0525

  • PRINCIPAL DISPLAY PANEL - 28.35 g Bottle Carton

    NDC 39328-019-01

    Urea 40%
    Topical Cream

    For External Use Only
    Not for Ophthalmic Use

    Rx Only

    Net Wt.
    28.35 g (1 oz.)

    PATRIN
    PHARMA

    Chemical Structure
  • INGREDIENTS AND APPEARANCE
    UREA 40% 
    urea cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:39328-019
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Cetyl alcohol (UNII: 936JST6JCN)  
    Dimethyl isosorbide (UNII: SA6A6V432S)  
    Glyceryl monostearate (UNII: 230OU9XXE4)  
    Mineral oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39328-019-011 in 1 CARTON10/01/2025
    128.35 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:39328-019-0385 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2025
    3NDC:39328-019-07198.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other10/01/2025
    Labeler - Patrin Pharma, Inc (806841677)
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