{"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: Each gram of Urea Topical Suspension contains 50% urea in a formulation consisting of caprylic/capric triglyceride, carbomer, cetyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, lactic acid, linoleic acid, PEG-6, polysorbate 60, propylene glycol, purified water, salicylic acid, sorbitan stearate, titanium dioxide, triethanolamine, vitamin E and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure: Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Apply Urea Topical Suspension to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed."],"effective_time":"20131007","how_supplied":["HOW SUPPLIED: Urea Topical Suspension 50% is supplied as: 284 g (10 oz) tube, NDC 0168-0493-84 Store at room temperature 15°-30° C (59°-86° F). Protect from freezing. Manufactured for: E. FOUGERA & CO. A division of Nycomed US Inc. Melville, New York 11747 Manufactured by: Pegasus Laboratories, Inc. Pensacola, FL 32514 IL339A R4/09"],"id":"734aac6a-94e4-460f-b2cb-6c24d478a317","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 pilaris, keratosis palmaris, keratoderma, corns and calluses."],"information_for_patients":["How to properly use fougera ® UREA TOPICAL SUSPENSION 50% In a lactic acid & salicylic acid vehicle Rx only Steps to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, eczema, corns and calluses. For skin: Apply Urea Topical Suspension to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. See other side for full prescribing information."],"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 Urea Topical Suspension is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 10 OZ CONTAINER NDC 0168-0493-84 Fougera ® UREA TOPICAL SUSPENSION 50% Net Wt. 10 oz (284 g) Container","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 10 OZ CARTON NDC 0168-0493-84 Fougera ® UREA TOPICAL SUSPENSION 50% Net Wt. 10 oz (284 g) 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 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 reproduction studies are not always predictive of human response, Urea Topical Suspension should be given to a pregnant woman only if clearly needed. 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 Urea Topical Suspension 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 reproduction studies are not always predictive of human response, Urea Topical Suspension should be given to a pregnant woman only if clearly needed."],"set_id":"cc6996f5-4313-42bc-8ede-5b25732a8e50","spl_product_data_elements":["Urea urea urea urea CETYL ALCOHOL EDETATE DISODIUM GLYCERIN LACTIC ACID LINOLEIC ACID POLYETHYLENE GLYCOL 300 POLYSORBATE 60 PROPYLENE GLYCOL WATER SALICYLIC ACID SORBITAN MONOSTEARATE TITANIUM DIOXIDE TROLAMINE ALPHA-TOCOPHEROL XANTHAN GUM"],"spl_unclassified_section":["In a lactic acid & salicylic acid vehicle Rx only For external use only. Not for ophthalmic use."],"version":"2","warnings":["WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes."]}