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 Corporation, SGS Canada Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Care Professional 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)

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: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
• Regular mail or Fax: Download form https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program 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/).

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

JB7127
3000 mL
DIN 00786160

0.9% Sodium Chloride
Irrigation USP

Chlorure de Sodium
à 0.9% pour Irrigation
USP

2D Barcode
(01)00809080000395

NaCl 0.9%
Irrigation

NOT FOR INJECTION / IRRIGATION ONLY
NE PAS INJECTER / POUR L’IRRIGATION
APPROX mOsmol /L – 308
APPROX pH 5.5

PER 100 mL – SODIUM CHLORIDE USP – 900 mg

PER 100 mL – CHLORURE DE SODIUM USP - 900 mg

CAUTIONS SINGLE USE / DISCARD UNUSED PORTION /
SQUEEZE AND INSPECT BAG / DO NOT USE IF THE OUTLET
PORT PROTECTOR IS DAMAGED DETACHED OR NOT PRESENT
AS SOLUTION PATH STERILITY MAY BE IMPAIRED / STORE AT
15°C TO 25°C

ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE /
PRESSER ET INSPECTER LE SAC / NE PAS UTILISER SI
L’EMBOUT DE PROTECTION DE L’ORIFICE DE SORTIE EST
ENDOMMAGÉ DÉTACHÉ OU ABSENT CAR LA STÉRILITÉ DE
LA CANALISATION POURRAIT ÊTRE COMPROMISE / GARDER
ENTRE 15°C TO 25°C

NONPYROGENIC / STERILE / APYROGENE

NaCl 0.9%

UROMATIC PVC CONTAINER/CONTENANT DE PVC

BAXTER AND UROMATIC ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
BAXTER ET UROMATIC SONT DES MARQUES DE COMMERCE DE BAXTER
INTERNATIONAL INC.

Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2

No Latex Label
07-25-77-352

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INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride irrigant

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9834
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: 0338-9834-04	4 in 1 CARTON	12/03/2024
1	NDC: 0338-9834-01	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		12/03/2024

Labeler - Baxter Healthcare Company (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Corporation		205087968	ANALYSIS(0338-9834) , LABEL(0338-9834) , MANUFACTURE(0338-9834) , STERILIZE(0338-9834) , PACK(0338-9834)

Establishment
Name	Address	ID/FEI	Business Operations
SGS Canada Inc		203668041	ANALYSIS(0338-9834)