{"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: Each gram contains 410 mg of urea in a vehicle consisting of: ceteareth-25, ceteareth-6, cetyl alcohol, methylparaben, paraffin, propylene glycol, propylparaben, purified water, stearyl alcohol, xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure: Urea is a diamide of carbonic acid with the following chemical structure:"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed. See package insert for full prescribing information."],"effective_time":"20211230","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): 8 oz. (227 g) bottles, NDC # 58657-486-08 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. 04/18"],"id":"d45ef5a6-32d9-32a5-e053-2995a90af51a","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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Urea 41 Cream For External Use Only Rx Only Net Wt. 8 oz. (277 g) Urea 41 Cream For External Use Only Rx Only Net Wt. 8 oz. (277 g)"],"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 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized."],"set_id":"96a025b6-d189-4372-8930-f4372c4aba68","spl_product_data_elements":["Urea 41 Percent Urea CETEARETH-25 CETEARETH-6 CETYL ALCOHOL METHYLPARABEN PARAFFIN PROPYLENE GLYCOL WATER STEARYL ALCOHOL XANTHAN GUM UREA UREA"],"spl_unclassified_section":["NDC 58657-48 6 -08 Urea 41% Cream For External Use Only Rx Only Net Wt. 8 oz. (227 g Urea 41% Cream Method Pharmaceuticals, LLC Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. ---------- Urea 41% Cream","NOTICE : Protect from freezing and excessive heat. Keep bottle tightly closed."],"version":"3","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."]}