{"effective_time":"20241203","health_care_provider_letter":["Health Care Professional 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 ) Reporting Adverse Events or Product Quality Issues To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1-800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: • Complete and submit the report Online : https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program • Regular mail or Fax : Download form https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program 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 these imported products, 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":"9bae43eb-2e68-4db1-8f2e-c73c98626654","openfda":{"brand_name":["Sodium Chloride"],"generic_name":["SODIUM CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Baxter Healthcare Company"],"package_ndc":["0338-9834-01","0338-9834-04"],"product_ndc":["0338-9834"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["IRRIGATION"],"rxcui":["486515"],"spl_id":["9bae43eb-2e68-4db1-8f2e-c73c98626654"],"spl_set_id":["464c2d78-5c88-4668-a039-56dd3c1c9b20"],"substance_name":["SODIUM CHLORIDE"],"unii":["451W47IQ8X"]},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL JB7127 3000 mL DIN 00786160 0.9% Sodium Chloride Irrigation USP Chlorure de Sodium à 0.9% pour Irrigation USP 2D Barcode (01)00809080000395 NaCl 0.9% Irrigation NOT FOR INJECTION / IRRIGATION ONLY NE PAS INJECTER / POUR L’IRRIGATION APPROX mOsmol /L – 308 APPROX pH 5.5 PER 100 mL – SODIUM CHLORIDE USP – 900 mg PER 100 mL – CHLORURE DE SODIUM USP - 900 mg CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE AND INSPECT BAG / DO NOT USE IF THE OUTLET PORT PROTECTOR IS DAMAGED DETACHED OR NOT PRESENT AS SOLUTION PATH STERILITY MAY BE IMPAIRED / STORE AT 15°C TO 25°C ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER ET INSPECTER LE SAC / NE PAS UTILISER SI L’EMBOUT DE PROTECTION DE L’ORIFICE DE SORTIE EST ENDOMMAGÉ DÉTACHÉ OU ABSENT CAR LA STÉRILITÉ DE LA CANALISATION POURRAIT ÊTRE COMPROMISE / GARDER ENTRE 15°C TO 25°C NONPYROGENIC / STERILE / APYROGENE NaCl 0.9% UROMATIC PVC CONTAINER/CONTENANT DE PVC BAXTER AND UROMATIC ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER ET UROMATIC SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC. Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 No Latex Label 07-25-77-352 2700 2400 2100 1800 1500 1200 900 600 300 Container Label NDC 0338-9834"],"set_id":"464c2d78-5c88-4668-a039-56dd3c1c9b20","spl_product_data_elements":["Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION"],"version":"2"}