{"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 Urea 39% cream is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin. Each gram contains 39% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax, glycerin, isopropyl myristate, purified water, sorbitol, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate. CHEMICAL STRUCTURE Urea is diamide of Carbonic acid with the following structure: Chemical 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":"20160223","how_supplied":["HOW SUPPLIED Urea 39% Cream is supplied in 227g NDC 67877-305-12 Store at 20-25°C (68-77°F) [see USP controlled room temperature]. Protect from freezing. Manufactured for: Manufactured by: Ascend Laboratories, LLC Crown Laboratories, Inc Montvale, NJ 07645 Johnson City, TN 37604 P6168.00"],"id":"20a8d7f1-7ee5-48fa-8269-f68374fa50b3","indications_and_usage":["INDICATIONS AND USAGE Urea 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":["ASCEND Laboratories, LLC NDC 67877-305-12 Urea Cream 39% For Topical Use Only Rx Only NET WT 8 oz (227g) product label"],"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":"b4ffb753-b4ba-4c4f-9304-bffa6448b06f","spl_product_data_elements":["Urea Urea Urea Urea DIMETHYL ISOSORBIDE GLYCERIN ISOPROPYL MYRISTATE WATER SORBITOL TRIDECYL STEARATE NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE TRIDECYL TRIMELLITATE"],"spl_unclassified_section":["ASCEND Laboratories, LLC Urea 39% Cream RX ONLY"],"version":"2","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucous membranes."]}