Medication reference

Urea

TOPICAL

Urea. Indications and Usage For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by loc

Urea

Brand names

Urea Cream 40 PercentUrea Cream 40%UREDEXUREAUREVEXUrea 41%Urea 40 PercentUrea 40%Urea Cream 41%

Active ingredients

UREA

Indications

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.

Dosage

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. 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.

Warnings

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.

Contraindications

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

Adverse reactions

Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at 1-877-250-3427; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Mechanism of action

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.

Available forms (71)

urea 0.1 MG/MG Topical Ointmenturea 0.2 MG/MG Topical Ointmenturea 0.45 MG/MG Topical Gelurea 0.47 MG/MG Topical Gelurea 0.4 MG/MG Topical Gelurea 0.5 MG/MG Pasteurea 0.5 MG/MG Topical Gelurea 0.5 MG/MG Topical Ointmenturea 100 MG/ML Medicated Shampoourea 100 MG/ML Topical Creamurea 100 MG/ML Topical Lotionurea 200 MG/ML Topical Creamurea 200 MG/ML Topical Foamurea 200 MG/ML Topical Solutionurea 220 MG/ML Topical Creamurea 250 MG/ML Topical Lotionurea 300 MG/ML Topical Creamurea 350 MG/ML Topical Creamurea 350 MG/ML Topical Foamurea 350 MG/ML Topical Lotionurea 375 MG/ML Topical Creamurea 390 MG/ML Topical Creamurea 395 MG/ML Topical Creamurea 400 MG/ML Topical Creamurea 400 MG/ML Topical Foamurea 400 MG/ML Topical Lotionurea 405 MG/ML Topical Creamurea 410 MG/ML Topical Creamurea 420 MG/ML Topical Creamurea 425 MG/ML Topical Creamurea 450 MG/ML Topical Creamurea 450 MG/ML Topical Lotionurea 450 MG/ML Topical Solutionurea 470 MG/ML Topical Creamurea 500 MG/ML Topical Creamurea 500 MG/ML Topical Lotionurea 500 MG/ML Topical Solutionurea 50 MG/ML Topical Creamurea 50 MG/ML Topical Lotionurea 0.1 MG/MG Topical Ointment [Aquaphilic with Urea]brandurea 0.45 MG/MG Topical Gel [CEM-Urea]brandurea 0.45 MG/MG Topical Gel [Uramaxin]brandurea 0.47 MG/MG Topical Gel [Kera Nail]brandurea 0.5 MG/MG Paste [Epimide 50]brandurea 100 MG/ML Medicated Shampoo [Carmol]brandurea 100 MG/ML Topical Cream [Aqua Care]brandurea 100 MG/ML Topical Cream [Nutraplus]brandurea 100 MG/ML Topical Lotion [Aqua Care]brandurea 100 MG/ML Topical Lotion [Carmol]brandurea 100 MG/ML Topical Lotion [Gormel 10]brandurea 100 MG/ML Topical Lotion [Nutraplus]brandurea 100 MG/ML Topical Lotion [Ureacin-10]brandurea 200 MG/ML Topical Cream [Carmol]brandurea 200 MG/ML Topical Cream [Gormel]brandurea 200 MG/ML Topical Cream [Ureacin-20]brandurea 200 MG/ML Topical Foam [Uramaxin]brandurea 250 MG/ML Topical Lotion [Ultra Mide]brandurea 300 MG/ML Topical Cream [Rea-Lo]brandurea 350 MG/ML Topical Foam [Hydro 35]brandurea 390 MG/ML Topical Cream [Rea Lo 39]brandurea 400 MG/ML Topical Cream [Aluvea]brandurea 400 MG/ML Topical Cream [Rea-Lo]brandurea 400 MG/ML Topical Cream [U-Kera]brandurea 400 MG/ML Topical Foam [Hydro 40]brandurea 400 MG/ML Topical Foam [Umecta]brandurea 400 MG/ML Topical Lotion [Rea-Lo]brandurea 410 MG/ML Topical Cream [Utopic]brandurea 420 MG/ML Topical Cream [Kera-42]brandurea 450 MG/ML Topical Cream [Uramaxin]brandurea 450 MG/ML Topical Lotion [Uramaxin]brandurea 470 MG/ML Topical Cream [Keralac]brand

NDC examples

58657-48971399-845685622-60124470-93944523-61863629-203663629-204085622-60585477-90571399-845571335-289024470-962

Indicated ICD-10 codes

Source: openFDA + RxNorm · 2026

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