{"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."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Use as directed by your physician. See label booklet for full Prescribing Information."],"effective_time":"20260424","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: Urea 40% Cream This product is supplied in the following size: 7oz NDC 63629-9267-1 Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504"],"id":"e91f44df-bbf1-484a-b84f-73ca9e47545e","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"],"manufacturer_name":["Bryant Ranch Prepack"],"original_packager_product_ndc":["58657-487"],"package_ndc":["63629-9267-1"],"product_ndc":["63629-9267"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"rxcui":["198342"],"spl_id":["e91f44df-bbf1-484a-b84f-73ca9e47545e"],"spl_set_id":["6701225c-2c2e-41e8-8d43-ef77c00a9946"],"substance_name":["UREA"],"unii":["8W8T17847W"]},"package_label_principal_display_panel":["Urea 40% Cream Label"],"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":"6701225c-2c2e-41e8-8d43-ef77c00a9946","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 structure"],"version":"103","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."]}