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.

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STERILE WATER FOR INJECTION, USP
(pH 5.0-7.0)

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


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

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

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

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

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


Serialization Label - 5 mL

Serialization Label - 5 mL

Serialization Label - 10 mL

Serialization Label - 10 mL

Serialization Label - 20 mL

Serialization Label - 20 mL
STERILE WATER 
water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0517-3005
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0517-3005-2525 in 1 TRAY09/30/199009/30/2021
1NDC:0517-3005-015 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/30/199009/30/2021
STERILE WATER 
water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0517-3010
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0517-3010-2525 in 1 TRAY04/22/2022
1NDC:0517-3010-0110 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/22/2022
STERILE WATER 
water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0517-3020
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0517-3020-2525 in 1 TRAY04/22/2022
1NDC:0517-3020-0120 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/22/2022
Labeler - American Regent, Inc. (002033710)
Establishment
NameAddressID/FEIBusiness Operations
American Regent, Inc.002033710analysis(0517-3005, 0517-3010, 0517-3020) , manufacture(0517-3005, 0517-3010, 0517-3020)

Revised: 1/2022
Document Id: b885fb92-786e-49bf-aed2-17b430e4743e
Set id: 78b35864-4bbc-4759-a5c1-7e4f25e22932
Version: 8
Effective Time: 20220131
 
American Regent, Inc.