Glucose And Sodium Chloride Injection, Solution
FDA Label NDC 0338-9799

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 Glucose And Sodium Chloride (NDC 0338-9799). 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)

Dhcp Letter 3.jpg (Image 03)

Dhcp Letter 3.jpg (Image 03)

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)

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)

Dhcp Letter 7.jpg (Image 07)

Dhcp Letter 7.jpg (Image 07)

Dhcp Letter 8.jpg (Image 08)

Dhcp Letter 8.jpg (Image 08)

Dhcp Letter 9.jpg (Image 09)

Dhcp Letter 9.jpg (Image 09)

Dhcp Letter 10.jpg (Image 10)

Dhcp Letter 10.jpg (Image 10)

Dhcp Letter 11.jpg (Image 11)

Dhcp Letter 11.jpg (Image 11)

Package/Label Principal Display Panel

A6c1064us Representative Carton Label 1 (Image 16)

A6c1064us Representative Carton Label 1 (Image 16)

A6c1064us Representative Carton Label 2.jpg (Image 17)

A6c1064us Representative Carton Label 2.jpg (Image 17)

Baxter Logo Trademark

A6C1064US

GLUCOSE AND
SODIUM CHLORIDE INJECTION

100

200

300

400

500

600

700

800

900

1000ml
5% GLUCOSE
0.9% SODIUM CHLORIDE

[Strength] 1000ml: glucose 50g
and sodium chloride 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: H19994068

AA

[Drug Marketing Authorization Holder] [Manufacturer]
Name: Baxter Healthcare (Shanghai) Co., Ltd.
Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

BarCode
(01) 00303389799016

LOT
MFG
EXP

5% Glucose/0.9% Sodium Chloride Injection

1000ml X 12

LOT S0000000 EXP YYYY-MM
A6C1064US 1C/N LIC H19994068

5% Glucose/0.9% Sodium Chloride Injection

1000ml X 12

LOT S0000000 EXP YYYY-MM
MFG YYYY-MM-DD 1C/N 0000

* Please review the disclaimer below.