0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection
SPL v4
SPL
SPL Set ID aaab14e7-a4b4-4b2b-8d73-ba688064a9b1
Route
INTRAVENOUS
Published
Effective Date 2024-11-21
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (9 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Active Since 2024-10-18

Description

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/ )


Medication Information

Description

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 Insert
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


Structured Label Content

Package Insert (PACKAGE INSERT)
Health Care Professional 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/)

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


Advanced Ingredient Data


Raw Label Data

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