Sodium Chloride Injection, Solution
FDA Label NDC 0338-9808

Full FDA labeling including 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 0338-9808). 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 package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package/Label Principal Display Panel

Sodium Chloride A6c1322us Respresentative Container Label.jpg (Image 12)

Sodium Chloride A6c1322us Respresentative Container Label.jpg (Image 12)

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

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Sodium Chloride A6c1323us Representative Container Label.jpg (Image 13jpg)

Sodium Chloride A6c1323us Representative Container Label.jpg (Image 13jpg)

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

Sodium Chloride A6c1324us Representative Container Label.jpg (Image 14)

Sodium Chloride A6c1324us Representative Container Label.jpg (Image 14)

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

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