SODIUM CHLORIDE irrigant

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Company, Baxter Healthcare Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Care Provider Letter

Please refer to the FDA-approved prescribing information for the drug product listed below:
0.9% Sodium Chloride Irrigation USP (click /DailyMed/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/)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride irrigant

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-0110
Route of Administration	IRRIGATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	900 mg  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-0110-04	4 in 1 CARTON	11/13/2024
1	NDC: 0338-0110-01	3000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		11/13/2024

Labeler - Baxter Healthcare Company (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Ltd		221478644	ANALYSIS(0338-0110) , LABEL(0338-0110) , MANUFACTURE(0338-0110) , PACK(0338-0110) , STERILIZE(0338-0110)