Package Insert and Label Information: Sterile Water
STERILE WATER- water injection, solution
American Regent, Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Rx Only
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.
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
PRINCIPLE DISPLAY PANEL – 5 mL Container
NDC 0517-3005-25
STERIL WATER FOR INJECTION, USP
5 mL SINGLE DOSE VIAL
FOR DRUG DILUENT USE
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
PRINCIPLE DISPLAY PANEL – 10 mL Container
NDC 0517-3010-25
STERIL WATER FOR INJECTION, USP
10 mL SINGLE DOSE VIAL
FOR DRUG DILUENT USE
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
PRINCIPLE DISPLAY PANEL – 20 mL Container
NDC 0517-3020-25
STERIL WATER FOR INJECTION, USP
20 mL SINGLE DOSE VIAL
FOR DRUG DILUENT USE
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
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| Labeler — American Regent, Inc. (622781813) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Luitpold Pharmaceuticals, Inc. | 002033710 | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | |
Revised: 12/2012 American Regent, Inc.
