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/)
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