{"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 470 mg of urea in a vehicle consisting of: camphor, EDTA, ethanol, Eucalyptus Oil 80-85, hydroxyethyl cellulose, menthol, purified water, sodium hydroxide, titanium dioxide. Urea is a diamide of carbonic acid with the following chemical structure: The following chemical structure for urea in a vehicle consisting of: camphor, EDTA, ethanol, Eucalyptus Oil 80-85, hydroxyethyl cellulose, menthol, purified water, sodium hydroxide, titanium dioxide."],"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."],"effective_time":"20180807","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: 5 oz. bottles, NDC 58657-488-05 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 R05/2018"],"id":"0144cdaa-a95c-465f-a457-41b5a78c87a6","indications_and_usage":["INDICATIONS AND USAGE: This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratosis 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 NDC 58657-488-05 Urea Cream 47 % For topical use Only Not for ophthalmic use Rx Only 5 oz (142 g) PRINCIPAL DISPLAY PANEL NDC 58657-488-05 Urea Cream 47 % For topical use Only Not for ophthalmic use Rx Only 5 oz (142 g)"],"pharmacokinetics":["Pharmacokinetics: The mechanism of action of topically applied urea is not yet known."],"precautions":["PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 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."],"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. NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed."],"set_id":"09dc828d-92c3-4ca5-924e-af425b0cdf2b","spl_product_data_elements":["Urea 47 urea UREA UREA HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) CAMPHOR (SYNTHETIC) EDETIC ACID ALCOHOL EUCALYPTUS OIL MENTHOL WATER SODIUM HYDROXIDE TITANIUM DIOXIDE"],"spl_unclassified_section":["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 47% Cream Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE."],"version":"1","warnings":["WARNINGS: KEEP OUT OF REACH OF CHILDREN."]}