{"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. 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 50% Urea Pre-filled applicator contains a keratolytic solution, which is a gentle, yet potent, tissue softener for nails and skin. Each mL contains 50% urea in a formulation consisting of: caprylic/capric triglyceride, disodium EDTA, hydroxyethylcellulose, lactic acid, PEG-6, polysorbate 60, propylene glycol, purified water sorbitan stearate, titanium dioxide, triethanolamine, urea, vitamin E, xanthan gum and zinc undecylenate. Urea is a diamide of carbonic acid with the following chemical structure: Chemical Stucture"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply 50% Urea solution to diseased or damaged nail tissue twice per day, or as directed by a physician."],"effective_time":"20111018","how_supplied":["HOW SUPPLIED 50% Urea Pre-filled applicator NDC 0168-0644-12, is supplied in a carton containing 1 -12 mL applicator. Store at controlled 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 IL352B R6/08"],"id":"99db5af9-7fee-4004-807c-d26c8d193cdd","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 50% Urea solution 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 – 12 ML LABEL NDC 0168-0644-12 12 mL Fougera Rx only 50% UREA Pre-filled applicator FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, LIPS OR MUCOUS MEMBRANES. KEEP OUT OF REACH OF CHILDREN. KEEP CONTAINER TIGHTLY CLOSED. DIRECTIONS: Apply 50% Urea solution to diseased or damaged nail or skin tissue twice a day, or as directed by a physician. Mfd for: E. FOUGERA & CO., A division of Nycomed US Inc., Melville New York 11747 Mfd. by: Pegasus Laboratories, Inc., Pensacola, FL 32514 Label","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 12 ML CARTON NDC 0168-0644-12 Fougera 50% UREA Pre-filled applicator FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, LIPS OR MUCOUS MEMBRANES. KEEP OUT OF REACH OF CHILDREN Rx only 12 mL E. FOUGERA & CO. A division of Nycomed US Inc. Melville, New York 11747 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 reproductive studies are not always predictive of human response, 50% Urea solution 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 50% Urea solution 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, 50% Urea solution should be given to a pregnant woman only if clearly needed."],"set_id":"d1a66233-315d-449f-a381-3d25408aecb4","spl_patient_package_insert":["PATIENT INSTRUCTIONS fougera ® 50% UREA Pre-filled applicator HOW TO USE Remove cap and twist top of applicator to right to open and unlock. Twist bottom dial to release medication. Note: When using for the first time, it will take a number of turns of the dial before solution appears. Using the sponge tip, apply a thin layer of 50% Urea solution to the surface of the nail(s) or skin as directed by physician. WARNING: Avoid contact with eyes, lips or mucous membranes. Replace cap immediately to prevent sponge applicator from drying out. Please see reverse side for full Prescribing Information. Twist Dial Apply Sponge Tip"],"spl_product_data_elements":["Urea Urea urea urea water edetate disodium titanium dioxide propylene glycol polysorbate 60 xanthan gum sorbitan monostearate alpha-tocopherol lactic acid zinc undecylenate trolamine"],"spl_unclassified_section":["For external use only. Not for ophthalmic use."],"version":"2","warnings":["WARNINGS For external use only. Avoid contact with eyes, lips or mucous membranes."]}