Sodium Chloride Irrigant
FDA Label NDC 0338-0110

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 Company for the product Sodium Chloride (NDC 0338-0110). 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 provider letter, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Health Care Provider Letter

Dhcp Letter 1 Of 7 (Image 01)

Dhcp Letter 1 Of 7 (Image 01)

Dhcp Letter 2 Of 7 (Image 02)

Dhcp Letter 2 Of 7 (Image 02)

Dhcp Letter 3 Of 7 (Image 03)

Dhcp Letter 3 Of 7 (Image 03)

Dhcp Letter 4 Of 7 (Image 04)

Dhcp Letter 4 Of 7 (Image 04)

Please refer to the FDA-approved prescribing information for the drug product listed below:
• 0.9% Sodium Chloride Irrigation USP (click https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=886f889b-f3cf-4197-b307-6cfa88c89436)

• 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 productqualityissues associated with this imported product, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (https://productfeedback.baxter.com/)

Dhcp Letter 5 Of 7 (Image 05)

Dhcp Letter 5 Of 7 (Image 05)

Dhcp Letter 6 Of 7 (Image 06)

Dhcp Letter 6 Of 7 (Image 06)

Dhcp Letter 7 Of 7 (Image 07)

Dhcp Letter 7 Of 7 (Image 07)

Package/Label Principal Display Panel

Container Label Ndc 0338-0110 (Image 08)

Container Label Ndc 0338-0110 (Image 08)

Container Label

REF 3KB7127 3000 ml

Baxter Logo

eng Sodium Chloride 0.9% for irrigation
UROMATIC container
Isotonic
Nonpyrogenic
Not for injection
Cautions
DO NOT USE FOR ELECTROSURGERY EXCEPT WITH A BIPOLER ELECTRODE
- Do not use unless solution is clear and container is undamaged
- Discard unused content of opened container
- Do not heat this container above 65°C

fre Chlorure de sodium à 0,9% pour irrigation

ger 0,9% Natriumchlorid zum Spülen

ita Sodio cloruro 0.9% per irrigazione

Formula
Natril Chloridum 9 g – Aqua ad injectabilia ad 1000 ml
mOsm/l 308

Do Not Re-Use Symbol
Consult Instructions for Use Symbol
European Conformity Symbol
Temperature Limit 25°C Symbol
Sterile Symbol

Manufacturer Symbol
Baxter Healthcare SA
8010 Zurich, Switzerland

Made in UK
TH-35-02-060

Lot Symbol
Use-by Date Symbol

2500

2000

1500

1000

500

* Please review the disclaimer below.