BACTERIOSTATIC SODIUM CHLORIDE

FDA Drug Profile — BACTERIOSTATIC SODIUM CHLORIDE

Drug Details

Generic Name
BACTERIOSTATIC SODIUM CHLORIDE
Brand Names
BACTERIOSTATIC SODIUM CHLORIDE
Application Number
NDA018800
Sponsor
HF Acquisition Co LLC, DBA HealthFirst
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
SODIUM CHLORIDE

Indications and Usage

INDICATIONS & USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

Warnings

WARNINGS Benzyl alcohol, a preservative in Bacteriostatic Sodium Chloride Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection should be used for flushing intravascular catheters. Where a sodium chloride solution is required for preparing or diluting medications for use in neonates, only preservative-free Sodium Chloride Injection should be used.