{"effective_time":"20241113","health_care_provider_letter":["Health Care Provider Letter Please refer to the FDA-approved prescribing information for the drug product listed below: • 0.9% Sodium Chloride Irrigation USP (click https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=886f889b-f3cf-4197-b307-6cfa88c89436 ) • Complete and submit the report Online : www.fda.gov/medwatch/report.htm • Regular mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178). To report product quality issues associated with this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal ( https://productfeedback.baxter.com/ ) DHCP Letter 1 of 7 DHCP Letter 2 of 7 DHCP Letter 3 of 7 DHCP Letter 4 of 7 DHCP Letter 5 of 7 DHCP Letter 6 of 7 DHCP Letter 7 of 7"],"id":"42b82754-49e1-4463-9679-99a8f443a7d4","openfda":{"brand_name":["Sodium Chloride"],"generic_name":["SODIUM CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Baxter Healthcare Company"],"package_ndc":["0338-0110-01","0338-0110-04"],"product_ndc":["0338-0110"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["IRRIGATION"],"rxcui":["486515"],"spl_id":["42b82754-49e1-4463-9679-99a8f443a7d4"],"spl_set_id":["99a15716-bbb9-4e33-a48d-20c58b81f392"],"substance_name":["SODIUM CHLORIDE"],"unii":["451W47IQ8X"]},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label REF 3KB7127 3000 ml Baxter Logo eng Sodium Chloride 0.9% for irrigation UROMATIC container Isotonic Nonpyrogenic Not for injection Cautions DO NOT USE FOR ELECTROSURGERY EXCEPT WITH A BIPOLER ELECTRODE - Do not use unless solution is clear and container is undamaged - Discard unused content of opened container - Do not heat this container above 65°C fre Chlorure de sodium à 0,9% pour irrigation ger 0,9% Natriumchlorid zum Spülen ita Sodio cloruro 0.9% per irrigazione Formula Natril Chloridum 9 g – Aqua ad injectabilia ad 1000 ml mOsm/l 308 Do Not Re-Use Symbol Consult Instructions for Use Symbol European Conformity Symbol Temperature Limit 25°C Symbol Sterile Symbol Manufacturer Symbol Baxter Healthcare SA 8010 Zurich, Switzerland Made in UK TH-35-02-060 Lot Symbol Use-by Date Symbol 2500 2000 1500 1000 500 Container Label NDC 0338-0110"],"set_id":"99a15716-bbb9-4e33-a48d-20c58b81f392","spl_product_data_elements":["Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION"],"version":"2"}