{"effective_time":"20241121","health_care_provider_letter":["HEALTH CARE PROFESSIONAL LETTER Please refer to the FDA approved package insert for the full prescribing information of the drug product as follows: • 0.9% Sodium Chloride Injection, USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=f55bd888-5e01-474d-871b-24654c070178&type=pdf&name=f55bd888-5e01-474d-871b-24654c070178 ) 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 : 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 these imported products, please contact Baxter Product Surveillance through Baxter Product Feedback Portal ( https://productfeedback.baxter.com/ ) DHCP Letter 1.jpg DHCP Letter 2.jpg DHCP Letter 3.jpg DHCP Letter 4.jpg DHCP Letter 5.jpg DHCP Letter 6.jpg"],"id":"fb0a01fb-897b-4cc1-9fb4-272a8009e411","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Baxter Logo Trademark A6C1322 SODIUM CHLORIDE INJECTION 50 100 150 200 250ml 0.9% Sodium Chloride [Strength] 250ml: 2.25g [Description] This product is a clear, colorless liquid [Dosage and Administration] Intravenous drip See the package insert for details For details of [Indications], [Adverse Reactions], [Contraindications], and [Precautions], please refer to the package insert [Storage] Store in overwrap The solution should be clear and should be used up at one time Inspect the inner bag by squeezing it and discard solution if leakage occurs License Number: H19994066 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai GTIN Barcode Area LOT MFG EXP Container Label Baxter Logo Trademark A6C1323 SODIUM CHLORIDE INJECTION 100 200 300 400 500ml 0.9% Sodium Chloride [Strength] 500ml: 4.5g [Description] This product is a clear, colorless liquid [Dosage and Administration] Intravenous drip See the package insert for details For details of [Indications], [Adverse Reactions], [Contraindications], and [Precautions], please refer to the package insert [Storage] Store in overwrap The solution should be clear and should be used up at one time Inspect the inner bag by squeezing it and discard solution if leakage occurs License Number: H19983148 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai GTIN Barcode Area LOT MFG EXP Container Label Baxter Logo Trademark A6C1324 SODIUM CHLORIDE INJECTION 100 200 300 400 500 600 700 800 900 1000ml 0.9% Sodium Chloride [Strength] 1000ml: 9g [Description] This product is a clear, colorless liquid [Dosage and Administration] Intravenous drip See the package insert for details For details of [Indications], [Adverse Reactions], [Contraindications], and [Precautions], please refer to the package insert [Storage] Store in overwrap The solution should be clear and should be used up at one time Inspect the inner bag by squeezing it and discard solution if leakage occurs License Number: H19983149 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai GTIN Barcode Area LOT MFG EXP Sodium Chloride A6C1322 Representative Container Label.jpg Sodium Chloride A6C1323 Representative Container Label.jpg Sodium Chloride A6C1324 Representative Container Label.jpg"],"set_id":"aaab14e7-a4b4-4b2b-8d73-ba688064a9b1","spl_product_data_elements":["Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER"],"spl_unclassified_section":["PACKAGE INSERT Spec303US Image 1.jpg Spec303US Image 2.jpg Spec303US Image 3.jpg Spec303US Image 4.jpg Spec301US Image 1.jpg Spec301US Image 2.jpg Spec301US Image 3.jpg Spec303US Image 4.jpg"],"version":"4"}