{"description":["Directions: Apply LIBERTAS PHARMA INC.'s 45% UREA NAIL GEL to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician."],"effective_time":"20170728","how_supplied":["Ingredients: Each gram of Libertas Pharma Inc.'s 45% Urea Nail Gel contains 45% Urea. Other ingredients include: Camphor, Disodium EDTA, Eucalyptus Oil, Hydroxyethylcellulose, Menthol, Propylene Glycol, and Purified Water. PLEASE SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION. Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing. Manufactured for: Libertas Pharma Inc. Lawrenceville, GA 30043 Rev. 7/11 181-28"],"id":"16eb680b-fd40-44fd-a115-41a868e7f03e","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 51862-181-28 Rx Only 45% Urea Nail Gel In a vehicle containing Camphor, Eucalyptus Oil and Menthol FOR TOPICAL USE ONLY 28 mL Bottle with Applicator Brush Libertas Pharma, Inc. Carton"],"precautions":["KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. If swallowed seek medical attention or contact a Poison Control Center immediately. USE ONLY AS DIRECTED BY A PHYSICIAN. CAUTION: If redness or irritation occurs, discontinue use. Avoid contact with eyes."],"set_id":"5ad3c07b-fee0-44e8-810e-dbfc6abac9ee","spl_product_data_elements":["Urea Urea UREA UREA CAMPHOR (SYNTHETIC) EDETATE DISODIUM EUCALYPTUS OIL HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER"],"spl_unclassified_section":["FOR TOPICAL USE ONLY 28 mL Bottle with Applicator Brush"],"storage_and_handling":["Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing. Manufactured for: Libertas Pharma Inc. Lawrenceville, GA 30043 Rev. 7/11 181-28"],"version":"3","warnings":["FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE."]}