Sterile Water for Injection

Dosage Form: injection, solution

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.

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.

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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




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

PRINCIPAL DISPLAY PANEL - 10 mL

Container

NDC 0517-3010-25

STERILE WATER
FOR INJECTION, USP

10 mL
SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN
REGENT, INC.

SHIRLEY, NY 11967




Carton

STERILE WATER
FOR INJECTION, USP

NDC 0517-3010-25
25 x 10 mL
SINGLE DOSE VIALS

FOR DRUG DILUENT USE

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




PRINCIPAL DISPLAY PANEL - 20 mL

NDC 0517-3020-25

STERILE WATER
FOR INJECTION, USP

20 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN
REGENT, INC.

SHIRLEY, NY 11967

PRINICPAL DISPLAY PANEL - 50 mL

NDC 0517-3050-25

STERILE WATER
FOR INJECTION, USP

50 mL
SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN
REGENT, INC.

SHIRLEY, NY 11967

STERILE WATER 
water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:0517-3005-25 25 VIAL, SINGLE-DOSE in 1 TRAY
1 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/30/1990
STERILE WATER 
water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:0517-3010-25 25 VIAL, SINGLE-DOSE in 1 TRAY
1 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/30/1990
STERILE WATER 
water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:0517-3020-25 25 VIAL, SINGLE-DOSE in 1 TRAY
1 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/30/1990
STERILE WATER 
water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-3050
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
1 NDC:0517-3050-25 25 VIAL, SINGLE-DOSE in 1 TRAY
1 50 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/1980
Labeler - American Regent, Inc. (622781813)
Establishment
Name Address ID/FEI Operations
Luitpold Pharmaceuticals, Inc. 002033710 ANALYSIS(0517-3005, 0517-3010, 0517-3020, 0517-3050), MANUFACTURE(0517-3005, 0517-3010, 0517-3020, 0517-3050), STERILIZE(0517-3005, 0517-3010, 0517-3020, 0517-3050)
Revised: 09/2014
 
American Regent, Inc.



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