{"adverse_reactions":["ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication."],"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. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate."],"contraindications":["CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients."],"description":["DESCRIPTION: Kylemore 50% Urea Ointment is a keratolytic emollient, which is a gentle, yet potent, tissue softener for skin. Each gram of Kylemore 50% Urea Ointment contains 50% Urea, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Edetate Disodium, Glycerin, Hydroxyethylcellulose, Lactic Acid, Linoleic Acid, PEG-6, Polysorbate 60, Propylene Glycol, Purified Water, Sorbitan Stearate, Tocopherol (Vitamin E), Triethanolamine, Xanthan Gum, and Zinc Pyrithione. Urea is a diamide of carbonic acid with the following chemical structure: structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Apply Kylemore 50% Urea Ointment to affected skin twice per day, or as directed by a physician."],"effective_time":"20110316","how_supplied":["HOW SUPPLIED: Kylemore 50% Urea Ointment is supplied as a 45g (1.5 oz) tube, NDC 68032-130-45 . Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing. Manufactured for: Kylemore Pharmaceuticals Port St. Joe, FL 32456 Rev. 12/09 130-10"],"id":"761e216a-91cb-436c-bf55-d4ef4f7bf233","indications_and_usage":["INDICATIONS AND USES: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses."],"nursing_mothers":["NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Kylemore 50% Urea Ointment is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"openfda":{},"package_label_principal_display_panel":["PACKAGING: Kylemore 50% Urea Ointment carton: carton"],"pharmacokinetics":["PHARMACOKINETICS: The mechanism of action of topically applied Urea is not yet known."],"precautions":["PRECAUTIONS: This medication 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."],"pregnancy":["PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Kylemore 50% Urea Ointment should be given to a pregnant woman only if clearly needed."],"set_id":"65474d48-dd2e-4fc1-9b88-f4d8a5b7b269","spl_product_data_elements":["Urea Urea UREA UREA MEDIUM-CHAIN TRIGLYCERIDES CARBOMER 934 CETYL ALCOHOL EDETATE DISODIUM GLYCERIN HYDROXYETHYL CELLULOSE (140 CPS AT 5%) LACTIC ACID LINOLEIC ACID POLYETHYLENE GLYCOL 300 POLYSORBATE 60 PROPYLENE GLYCOL WATER SORBITAN MONOSTEARATE ALPHA-TOCOPHEROL TROLAMINE XANTHAN GUM PYRITHIONE ZINC"],"version":"5","warnings":["WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes."]}