Bacteriostatic Water

FDA Drug Profile — Bacteriostatic Water

Bacteriostatic Water is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Bacteriostatic Water. Available dosage form: injection, solution.

Drug Details

Generic Name
Bacteriostatic Water
Brand Names
Bacteriostatic Water
Application Number
NDA018802
Sponsor
Hospira, Inc.
NDC Codes
4
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
WATER

Indications and Usage

INDICATIONS AND 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 Water for Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used. Intravenous administration of Bacteriostatic Water for Injection without a solute may result in hemolysis.