Bacteriostatic Water
Drug Details
- Generic Name
- Bacteriostatic Water
- Brand Names
- Bacteriostatic Water
- Application Number
- NDA018802
- Sponsor
- Fujian Genohope Biotech Ltd.
- NDC Codes
- 3
- Dosage Forms
- SOLUTION, INJECTION, SOLUTION
- Routes
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Active Ingredients
- BENZYL ALCOHOL, 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.