{"adverse_reactions":["ADVERSE REACTIONS Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Urea cream 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."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients."],"description":["DESCRIPTION DERMASORB™XM (Urea 39%) Cream is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin. Each gram contains 390 mg Urea as the active ingredient and the following inactive ingredients: Dimethyl Isosorbide, Emulsifying Wax NF, Glycerin, Isopropyl Myristate, Purified Water, Sorbitol, Tridecyl Stearate and Neopentyl Glycol Dicaprylate/Dicaprate and Tridecyl Trimellitate. Urea is diamide of carbonic acid with the following structure: Urea Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN"],"effective_time":"20190520","how_supplied":["HOW SUPPLIED DERMASORB™XM (Urea 39%) Cream is supplied in: 227g NDC 0316-0204-01 Store at room temperature 15˚C - 30˚C (59˚F - 86˚F). Protect from freezing. Manufactured and distributed by: Crown Laboratories, Inc. Johnson City, TN 37604 Rx Only P9471.00"],"id":"8956700f-f819-1beb-e053-2995a90a7bf2","indications_and_usage":["INDICATION AND USAGE DERMASORB™XM (Urea 39%) Cream 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."],"nursing_mothers":["Nursing Mothers It is not known whether urea cream is excreted in human milk, therefore caution should be exercised when administering to a nursing mother."],"openfda":{},"package_label_principal_display_panel":["Dermasorb XM Complete Kit p947400 Dermasorb XM Trade Carton"],"pharmacokinetics":["PHARMACOKINETICS The exact mechanism of action of topically applied urea is not known."],"precautions":["PRECAUTIONS Urea cream should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use."],"pregnancy":["Pregnancy: Category C Animal reproduction studies have not been conducted with urea cream. It is also not known whether urea cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Urea cream should be given to a pregnant woman only if clearly needed."],"set_id":"95e5f86e-897b-4ef9-a514-6b003387f84c","spl_product_data_elements":["Dermasorb XM Complete Kit Urea Cream with Moisturizing Cream Dermasorb XM 39% Urea Cream DIMETHYL ISOSORBIDE POLAWAX POLYSORBATE GLYCERIN ISOPROPYL MYRISTATE WATER SORBITOL TRIDECYL STEARATE NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE TRIDECYL TRIMELLITATE UREA UREA Dermasorb Extreme Moisturizer WATER PETROLATUM GLYCERIN LIGHT MINERAL OIL CETYL ALCOHOL STEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER SODIUM P-CHLORO-M-CRESOL"],"version":"2","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucous membranes."]}