Description:
Sterile Water for Injection, USP is water for injection sterilized and packaged in single dose vials. It contains no antimicrobial agents or other preservatives. It is used as a diluent. Non-pyrogenic.
Sterile Water Injection, Solution
FDA Label NDC 0517-3020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Regent, Inc. for the product Sterile Water (NDC 0517-3020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description:, precautions:, how supplied:, principal display panel - 5 ml, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Precautions:
Unused amount should be discarded immediately following withdrawal of any portion of vial contents. Sterile Water for Injection is not isotonic and should not be injected directly into the body.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
How Supplied:
Sterile Water for Injection, USP
| NDC 0517-3005-25 | 5 mL Single Dose Vial | Packaged in 25 |
| NDC 0517-3010-25 | 10 mL Single Dose Vial | Packaged in 25 |
| NDC 0517-3020-25 | 20 mL Single Dose Vial | Packaged in 25 |
| NDC 0517-3050-25 | 50 mL Single Dose Vial | Packaged in 25 |
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
IN3005
Rev. 1/09
Principal Display Panel - 5 Ml
Container
NDC 0517-3005-25
STERILE WATER
FOR INJECTION, USP
5 mL SINGLE DOSE VIAL
FOR DRUG DILUENT USE
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
Container (Sterile Water 1)
Carton
STERILE WATER
FOR INJECTION, USP
NDC 0517-3005-25
25 x 5 mL
SINGLE DOSE VIALS
FOR DRUG DILUENT USE
Rx Only
No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Rev. 11/05
Carton (Sterile Water 2)
* Please review the disclaimer below.
