{"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. PHARMACOKINETICS The mechanism of action of topically applied Urea is not yet known."],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the listed ingredients."],"description":["DESCRIPTION 45% Urea Lotion is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of 45% Urea Lotion contains 45% Urea in a formulation consisting of Camphor, Disodium EDTA, Alcohol SDA 40, Eucalyptus Oil, Hydroxyethylcellulose, Menthol, Water and Titanium Dioxide. Urea is a diamide of carbonic acid with the following chemical structure: Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply 45% Urea Lotion to affected skin twice per day, or as directed by a physician."],"effective_time":"20180103","how_supplied":["HOW SUPPLIED 45% Urea Lotion is supplied as a 16oz bottle, NDC 61269-182-16 Store at controlled room temperature 15° - 30°C (59° - 86°F). Protect from freezing. Manufactured for: H2-Pharma, LLC Montgomery, AL 36117 www.h2-pharma.com Rev. 10/16 182-16"],"id":"03db50e7-4747-4192-bee3-5270a6d2576f","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 secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when 45% Urea Lotion is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 454 g Bottle Label NDC 61269-182-16 Rx Only 45% Urea Lotion 45% Urea In a vehicle containing Camphor, Eucalyptus Oil and Menthol FOR TOPICAL USE ONLY Net Wt. 16 oz. H 2 pharma PRINCIPAL DISPLAY PANEL - 454 g Bottle Label"],"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 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, 45% Urea Lotion should be given to a pregnant woman only if clearly needed. NURSING MOTHERS It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when 45% Urea Lotion is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"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, 45% Urea Lotion should be given to a pregnant woman only if clearly needed."],"set_id":"5fe0c3e1-fbf0-402a-becc-bd9e267d3187","spl_product_data_elements":["Urea UREA UREA UREA CAMPHOR (SYNTHETIC) EDETATE DISODIUM ALCOHOL EUCALYPTUS OIL HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) MENTHOL, UNSPECIFIED FORM WATER TITANIUM DIOXIDE"],"spl_unclassified_section":["Rx Only For external use only. Not for ophthalmic use."],"storage_and_handling":["Store at controlled room temperature 15° - 30°C (59° - 86°F). Protect from freezing. Manufactured for: H2-Pharma, LLC Montgomery, AL 36117 www.h2-pharma.com Rev. 10/16 182-16"],"teratogenic_effects":["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, 45% Urea Lotion should be given to a pregnant woman only if clearly needed."],"version":"3","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucus membranes."]}