{"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: Urea Nailstick 50% is a keratolytic solution, which is a gentle, yet potent, tissue softener for nails. Each mL of Urea Nailstick 50% contains 50% Urea and the following inactive ingredients: disodium EDTA, hydroxyethylcellulose, lactic acid, PEG-6, propylene glycol, purified water, triethanolamine, xanthan gum and zinc pyrithione. Urea is a diamide of carbonic acid with the following chemical structure: Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Apply Urea Nailstick 50% to diseased or damaged nail tissue twice per day, or as directed by a physician."],"effective_time":"20140117","how_supplied":["HOW SUPPLIED: Urea Nailstick 50% is supplied in a carton containing 6 NAILSTICKS 2.4 mL each, NDC 0168-0491-14 Store at 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 IL285A R4/09 ---------- How to use Fougera ® UREA NAILSTICK 50% In a vehicle containing lactic acid and zinc 1. Remove cap and twist dial at the bottom of the Urea Nailstick 50% until a small amount of solution appears on the sponge tip. Note: When using Urea Nailstick 50% for the first time, it will take a number of turns of the dial before solution appears. 2. Using the sponge tip, apply a thin layer of Urea Nailstick 50% to the surface of the nail(s) as directed by physician. 3. Replace cap immediately to prevent sponge applicator from drying out. Please see reverse side for full Prescribing Information. ----------"],"id":"04a4aa89-34be-4048-b233-a2c48b980a26","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, as well as damaged, devitalized and ingrown nails."],"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 Nailstick 50% 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 – 2.4 mL LABEL NDC 0168-0491-14 2.4 mL Fougera ® UREA NAILSTICK 50% Rx only Tube Label","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 2.4 mL CARTON NDC 0168-0491-14 Fougera ® UREA NAILSTICK 50% For Topical Use Only Six-2.4 ml applicators Rx only Carton 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, Urea Nailstick 50% 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 Nailstick 50% is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication."],"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, Urea Nailstick 50% should be given to a pregnant woman only if clearly needed."],"set_id":"c2f562a5-920e-4d1b-9ad5-ef5dd2e68a14","spl_product_data_elements":["Urea Urea UREA urea EDETATE DISODIUM LACTIC ACID POLYETHYLENE GLYCOL 300 TROLAMINE XANTHAN GUM PYRITHIONE ZINC WATER"],"spl_unclassified_section":["Rx only In a vehicle containing lactic acid and zinc For external use only. Not for Ophthalmic Use."],"version":"1","warnings":["WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes."]}