{"adverse_reactions":["ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["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."],"clinical_pharmacology":["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."],"contraindications":["CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product."],"description":["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. desc"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Use as directed by your physician. See label booklet for full Prescribing Information."],"effective_time":"20260212","general_precautions":["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."],"how_supplied":["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"],"id":"4aad643a-b8f7-e2cb-e063-6394a90affec","indications_and_usage":["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."],"information_for_patients":["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."],"nursing_mothers":["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."],"openfda":{"brand_name":["Urea 40 Percent"],"generic_name":["UREA"],"is_original_packager":[true],"manufacturer_name":["Method Pharmaceuticals, LLC"],"package_ndc":["58657-487-07","58657-487-01","58657-487-03"],"product_ndc":["58657-487"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"rxcui":["198342"],"spl_id":["4aad643a-b8f7-e2cb-e063-6394a90affec"],"spl_set_id":["d35b75e1-937d-ebc4-e053-2a95a90ac0d8"],"substance_name":["UREA"],"unii":["8W8T17847W"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL label1 label2 label3"],"pharmacokinetics":["Pharmacokinetics: The mechanism of action of topically applied urea is not yet known."],"pregnancy":["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."],"safe_handling_warning":["STORAGE: Store at room temperature 15°C-30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed."],"set_id":"d35b75e1-937d-ebc4-e053-2a95a90ac0d8","spl_product_data_elements":["Urea 40 Percent Urea GLYCERIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETYL ALCOHOL WHITE PETROLATUM MINERAL OIL WATER GLYCERYL STEARATE SE UREA UREA"],"version":"8","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."]}