0.9% sodium chloride injection

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)

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

Barcode

(01)00303389791010

LOT

MFG

EXP

0.9% Sodium Chloride Injection

250ml X 40

LOT S0000000 EXP YYYY-MM

A6C1322US 1C/N LIC H19994066

0.9% Sodium Chloride Injection

250ml X 40

LOT S0000000 EXP YYYY-MM

MFG YYYY-MM-DD 1C/N 0000

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

Barcode

(01)00303389808015

LOT

MFG

EXP

0.9% Sodium Chloride Injection

500ml X 24

LOT S0000000 EXP YYYY-MM

A6C1323US 1C/N LIC H19983148

0.9% Sodium Chloride Injection

500ml X 24

LOT S0000000 EXP YYYY-MM

MFG YYYY-MM-DD 1C/N 0000

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

Barcode

(01)00303389793014

LOT

MFG

EXP

0.9% Sodium Chloride Injection

1000ml X 12

LOT S0000000 EXP YYYY-MM

A6C1324US 1C/N LIC H19983149

0.9% Sodium Chloride Injection

1000ml X 12

LOT S0000000 EXP YYYY-MM

MFG YYYY-MM-DD 1C/N 0000

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)

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

Barcode

(01)00303389791010

LOT

MFG

EXP

0.9% Sodium Chloride Injection

250ml X 40

LOT S0000000 EXP YYYY-MM

A6C1322US 1C/N LIC H19994066

0.9% Sodium Chloride Injection

250ml X 40

LOT S0000000 EXP YYYY-MM

MFG YYYY-MM-DD 1C/N 0000

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

Barcode

(01)00303389808015

LOT

MFG

EXP

0.9% Sodium Chloride Injection

500ml X 24

LOT S0000000 EXP YYYY-MM

A6C1323US 1C/N LIC H19983148

0.9% Sodium Chloride Injection

500ml X 24

LOT S0000000 EXP YYYY-MM

MFG YYYY-MM-DD 1C/N 0000

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

Barcode

(01)00303389793014

LOT

MFG

EXP

0.9% Sodium Chloride Injection

1000ml X 12

LOT S0000000 EXP YYYY-MM

A6C1324US 1C/N LIC H19983149

0.9% Sodium Chloride Injection

1000ml X 12

LOT S0000000 EXP YYYY-MM

MFG YYYY-MM-DD 1C/N 0000