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FDA Drug information

Sodium Chloride

Read time: 1 mins
Marketing start date: 12 Jan 2025
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Summary of product characteristics


Effective Time

20240906

Version

1

Spl Product Data Elements

Sodium Chloride SODIUM CHLORIDE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Sodium Chloride SODIUM CHLORIDE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER

Brand Name

Sodium Chloride

Generic Name

SODIUM CHLORIDE

Product Ndc

0990-5138

Product Type

HUMAN PRESCRIPTION DRUG

Route

IRRIGATION

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label 250 mL Sterile Solution DIN 00037834 N° 06138125 AQUALITE™ 0.9% Sodium Chloride Irrigation USP For Intraperitoneal, Irrigation and Topical Use • NOT FOR INJECTION • Nonpyrogenic • Single-Use Use only if solution is clear and seal intact. Discard unused portion. Each mL contains: Sodium chloride 9 mg. May contain NaOH/HCl for pH adjustment. Contains no bacteriostat. Dosage: As directed. Do not heat over 66°C. Storage: 20 to 25°C. Protect from freezing. pH approx. 5.6 Questions or Concerns ICU Medical Canada Inc. Saint-Laurent, QC H4S 0A9 RL-7298 LOT EXP Principal Display Panel - 250 mL Bottle Label

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