Sodium Chloride Injection: Package Insert / Prescribing Info

HEALTH CARE PROFESSIONAL LETTER

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.

To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter - Product Feedback Portal (https://productfeedback.baxter.com/).

Please also refer to the local prescribing information of the imported product, translated into English, available for:
• 0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723233)
• 5% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723235)
• 10% Glucose Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723237)
• 5% Glucose/0.9% Sodium Chloride Injection (click https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/723238)

Please refer to the FDA-approved prescribing information for each drug product listed below:
• 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)
• 5% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5)
• 10% Dextrose Injection USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5&type=pdf&name=3bb406a9-f5cb-403a-b1bb-5c4facbea3d5)
• 5% Dextrose/0.9% Sodium Chloride Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016678s007,016683s103,016687s104,016689s107,016697s098lbl.pdf)

PACKAGE INSERT

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label

Baxter Logo Trademark

A6C1322US

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

A6C1323US

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

A6C1324US

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