{"effective_time":"20250509","health_care_provider_letter":["Health Care Provider Letter DHCP Letter - 1 DHCP Letter - 2 DHCP Letter - 3 DHCP Letter - 4 DHCP Letter - 5 DHCP Letter - 6"],"id":"34c03c8d-fcd6-dcc6-e063-6294a90a97f1","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL FNB4974 2000 mL (APPROX 80 mL EXCESS) Baxter Logo EXTRANEAL Peritoneal Dialysis Solution with 7.5% lcodextrin EACH 100 mL CONTAINS 7.5 g ICODEXTRIN 538 mg SODIUM CHLORIDE USP 448 mg SODIUM LACTATE 25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM CHLORIDE USP pH 5.2 (5.0 TO 6.0) mmol/L SODIUM 132 CALCIUM 1.75 MAGNESIUM 0.25 CHLORIDE 96 LACTATE 40 OSMOLARITY 284 mOsmol/L (CALC) STERILE NONPYROGENIC STORE BELOW 30°C SEE INSERT FOR INTRAPERITONEAL ADMINISTRATION ONLY NOT FOR INTRAVENOUS USE CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION KEEP OUT OF REACH OF CHILDREN MANUFACTURED BY BAXTER HEALTHCARE SA, SINGAPORE BRANCH 2 WOODLANDS INDUSTRIAL PARK D STREET 2 SINGAPORE 737778 (AN AFFILIATE OF BAXTER HEALTHCARE CORPORATION USA) DIRECTION TO BE USED AS DIRECTED BY PHYSICIAN FOR HONG KONG ONLY: PRESCRIPTION DRUG IMPORTED BY BAXTER HEALTHCARE (THAILAND) CO., LTD., BANGKOK FOR MALAYSIA ONLY: CONTROLLED MEDICINE. JAUHI DARIPADA KANAK-KANAK PRODUCT REGISTRATION HOLDER: BAXTER HEALTHCARE (MALAYSIA) SDN. BHD., B-21-3A, THE ASCENT, PARADIGM, 1, JLN SS7/26A, 47301 PJ SELANGOR, MALAYSIA AMBU-FLEX CONTAINER PL-146 SIN11220P MAL06021264AZ HK-46627 BRU13021011P THAI REG. NO. 2C 16/51 (N) EXTRANEAL, AMBU-FLEX and PL-146 are trademarks of Baxter International Inc. 3A-00001 FNB4974SG barcode 7.5% ICODEXTRIN EXTRANEAL 6 X 2000 ML MAL 06021264AZ LOT: barcode Barcode 18806466013115 LOT: S24A12345 EXP: 12.12.2024 Extraneal Representative Carton Label Extraneal Representative Carton Label"],"set_id":"ba547994-e2d1-450e-b10b-39264d00dc8c","spl_product_data_elements":["EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride WATER HYDROCHLORIC ACID SODIUM HYDROXIDE ICODEXTRIN ICODEXTRIN SODIUM CHLORIDE SODIUM CATION CHLORIDE ION SODIUM LACTATE SODIUM CATION LACTIC ACID, UNSPECIFIED FORM CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION"],"version":"3"}