{"effective_time":"20170504","id":"c40dacc6-de2f-4a7f-af42-26501eff74b5","openfda":{"application_number":["NDA017867"],"brand_name":["Sodium Chloride"],"generic_name":["SODIUM CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Baxter Healthcare Company"],"package_ndc":["0338-0047-44","0338-0047-46","0338-0047-47"],"product_ndc":["0338-0047"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["IRRIGATION"],"rxcui":["486515"],"spl_id":["c40dacc6-de2f-4a7f-af42-26501eff74b5"],"spl_set_id":["886f889b-f3cf-4197-b307-6cfa88c89436"],"substance_name":["SODIUM CHLORIDE"],"unii":["451W47IQ8X"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - PACKAGING LABELING 3000 mL 2B77127 NDC 0338-0047-47 NOT FOR INJECTION 0.9% SODIUM CHLORIDE Irrigation USP Each 100 mL contains 900 mg Sodium Chloride USP No antimicrobial agent has been added pH 5.5 (4.5 to 7.0) mEq/L Sodium 154 Chloride 154 Osmolarity 308 mOsmol/L (calc) Sterile Nonpyrogenic Single dose container Do not use unless solution is clear Discard unused portion Cautions 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 0.9% Sodium Chloride NaCl Irrigation USP UROMATIC container PL 146 plastic BAXTER UROMATIC and PL 146 are trademarks of Baxter International Inc For product information 1-800-933-0303 Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in Mexico 2700 2400 2100 1800 1500 1200 900 600 300 Representative Container Label 0338-0047-44"],"set_id":"886f889b-f3cf-4197-b307-6cfa88c89436","spl_product_data_elements":["Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION Water"],"spl_unclassified_section":["Directions for Use of Flexible Plastic Irrigation Containers If desired, warm in overwrap to near body temperature 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 Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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. 1. Suspend container using hanger hole. 2. Remove plastic protector from outlet port at bottom of container. 3. Attach irrigation set. Refer to complete directions accompanying 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 Mexico ©Copyright 1980, 1984, 1989, Baxter Healthcare Corporation. All rights reserved. Rev. May 2017 88-80-31-833"],"version":"12"}