Sodium Chloride Injection, Solution
FDA Label NDC 0338-9804

2 label sections · Submitted to the FDA by Baxter Healthcare Corporation · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Corporation for the product Sodium Chloride (NDC 0338-9804). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding health care professional letter, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Health Care Professional Letter

Dhcp Letter 1.jpg (Image 01)

Dhcp Letter 1.jpg (Image 01)

Dhcp Letter 2.jpg (Image 02)

Dhcp Letter 2.jpg (Image 02)

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 3.jpg (Image 03)

Dhcp Letter 3.jpg (Image 03)

Dhcp Letter 4.jpg (Image 04)

Dhcp Letter 4.jpg (Image 04)

Dhcp Letter 5.jpg (Image 05)

Dhcp Letter 5.jpg (Image 05)

Dhcp Letter 6.jpg (Image 06)

Dhcp Letter 6.jpg (Image 06)

Package/Label Principal Display Panel

Sodium Chloride A6c1322 Representative Container Label.jpg (Image 15)

Sodium Chloride A6c1322 Representative Container Label.jpg (Image 15)

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

Sodium Chloride A6c1323 Representative Container Label.jpg (Image 16)

Sodium Chloride A6c1323 Representative Container Label.jpg (Image 16)

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

Sodium Chloride A6c1324 Representative Container Label.jpg (Image 17)

Sodium Chloride A6c1324 Representative Container Label.jpg (Image 17)

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

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