Sterile Water: Package Insert and Label Information

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

NOT FOR DIRECT INJECTION

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

PRINCIPAL DISPLAY PANEL — 5 mL

Contain

NDC 0517-3005-01

STERILE WATER
FOR INJECTION, USP

5 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

5 mL container label
(click image for full-size original)

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
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL

Container

NDC 0517-3010-01

STERILE WATER
FOR INJECTION, USP

10 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

10 mL container label
(click image for full-size original)

Carton
STERILE WATER
FOR INJECTION, USP
NDC 0517-3010-25
25 x 10 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 Labeling -- 10 mL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL

Container

NDC 0517-3020-01

STERILE WATER
FOR INJECTION, USP

20 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

20 mL container label
(click image for full-size original)

Carton
STERILE WATER
FOR INJECTION, USP
NDC 0517-3020-25
25 x 20 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. 5/18

Carton Labeling -- 20 mL
(click image for full-size original)

Serialization Label — 5 mL

Serialization Label -- 5 mL
(click image for full-size original)

Serialization Label — 10 mL

Serialization Label -- 10 mL
(click image for full-size original)

Serialization Label — 20 mL

Serialization Label -- 20 mL
(click image for full-size original)
STERILE WATER water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-3005
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-3005-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0517-3005-01)
1 NDC:0517-3005-01 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-3005-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/30/1990 09/30/2021
STERILE WATER water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-3010
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-3010-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0517-3010-01)
1 NDC:0517-3010-01 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-3010-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/22/2022
STERILE WATER water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-3020
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-3020-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0517-3020-01)
1 NDC:0517-3020-01 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-3020-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/22/2022
Labeler — American Regent, Inc. (002033710)
Establishment
Name Address ID/FEI Operations
American Regent, Inc. 002033710 analysis (0517-3005), analysis (0517-3010), analysis (0517-3020), manufacture (0517-3005), manufacture (0517-3010), manufacture (0517-3020)

Revised: 01/2022 American Regent, Inc.

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