{"effective_time":"20111214","id":"043b322b-722f-49e1-ad00-7303c2d5fe64","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - PACKAGING LABELING Container Label 2000 mL 2B7176 NDC 0338-0041-46 NOT FOR INJECTION 0.45% SODIUM CHLORIDE Irrigation USP EACH 100 mL CONTAINS 450 mg SODIUM CHLORIDE USP NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 5.5 (4.5 TO 7.0) mEq/L SODIUM 77 CHLORIDE 77 OSMOLARITY 154 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION CAUTIONS THIS SOLUTION IS HYPOTONIC AND MAY BE HEMOLYTIC SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT 0.45% Sodium Chloride NaCl Irrigation USP UROMATIC CONTAINER PL146 PLASTIC Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA FOR PRODUCT INFORMATION 1-800-933-0303 BAXTER UROMATIC AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC Carton Label 2B7176 6-2000 ML UROMATIC CONTAINER 0.45% SODIUM CHLORIDE IRRIGATION, USP EXP XXXXX SECONDARY BAR CODE (17)YYMM00 (10) XXXXX LOT XXXXX PRIMARY BAR CODE (01) 50303380041461 Sodium Chloride Representative Container Label Sodium Chloride Representative Carton Label"],"set_id":"8d180c83-dc54-40f2-8fe2-7c80a663714a","spl_product_data_elements":["Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION WATER"],"spl_unclassified_section":["If desired, warm in overwrap in a water bath or oven heated to not more than 45°C. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.","DIRECTIONS FOR USE To open, tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Use Aseptic Technique For complete system preparation, see directions accompanying irrigation set. Suspend container from eyelet support. Close control clamp of irrigation set. Remove protector from outlet port. Insert connector of set into port. Proceed with instructions provided with irrigation set. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.","Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA 07-19-44-645 Rev. August 2004 Baxter is a trademark of Baxter International Inc."],"version":"2"}