{"adverse_reactions":["ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088."],"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: River’s Edge 50% Urea Nail Stick is a keratolytic solution, which is a gentle, yet potent, tissue softener for nails. Each mL of River’s Edge 50% Urea Nail Stick contains 50% Urea, Disodium EDTA, Hydroxyethylcellulose, Lactic Acid, Propylene Glycol, Purified Water, Triethanolamine, Xanthan Gum and Zinc Pyrithione."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Apply River’s Edge 50% Urea Nail Stick to diseased or damaged nail tissue twice per day, or as directed by a physician."],"effective_time":"20101220","how_supplied":["HOW SUPPLIED: River’s Edge 50% Urea Nail Stick , NDC 68032-131-06, is supplied in a carton containing 6 NAILSTICKS (2.4 mL each). Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing. Manufactured for: River's Edge Pharmaceuticals, LLC Suwanee, GA 30024 Rev. 09/09 131-12"],"id":"1f0725a3-3500-4864-be48-d41acdc47c31","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, as well as damaged, devitalized, and ingrown nails."],"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 River’s Edge 50% Urea Nail Stick is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"openfda":{},"package_label_principal_display_panel":["PACKAGING: 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: 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, River’s Edge 50% Urea Nail Stick should be given to a pregnant woman only if clearly needed."],"set_id":"c0064a5b-c569-4c8c-84b8-2418cdedf6f4","spl_product_data_elements":["UREA UREA UREA UREA EDETATE DISODIUM HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) LACTIC ACID PROPYLENE GLYCOL WATER TROLAMINE XANTHAN GUM PYRITHIONE ZINC"],"version":"11","warnings":["WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes."]}