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FDA Drug information

Sodium Chloride

Read time: 1 mins
Marketing start date: 26 Jan 2025
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Summary of product characteristics


Effective Time

20241203

Version

1

Spl Product Data Elements

Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION

Brand Name

Sodium Chloride

Generic Name

Sodium Chloride

Product Ndc

0338-9834

Product Type

HUMAN PRESCRIPTION DRUG

Route

IRRIGATION

Package Label Principal Display Panel

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 2700 2400 2100 1800 1500 1200 900 600 300 Container Label NDC 0338-9834

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