Water for Injection

Name: Water for Injection

Water for Injection Description

This preparation is designed solely for parenteral use only after addition to drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.

Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of Water for Injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection.  For IV injection, add sufficient amount to a solute to make an approximately isotonic solution. pH 5.0 to 7.0.

Water for Injection, USP is chemically designated H2O.

Contraindications

Sterile Water for Injection must be made approximately isotonic prior to use.

Warnings

Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.

Where Water for Injection is required for preparing or diluting medications for use in newborns, only preservative-free Sterile Water for Injection should be used.

Adverse Reactions

Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.  If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

How is Water for Injection Supplied

Product

No.

NDC

No.

Volume

918501

63323-185-01

1 mL in a 3 mL vial

918510

63323-185-10

10 mL in a 10 mL vial

918520

63323-185-20

20 mL in a 20 mL vial

918550

63323-185-50

50 mL in a 50 mL vial

Packaged in a plastic vial.  Vials are packaged 25 vials per tray.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Single dose use.  No preservative added.

Unused portion of vial should be discarded.

Use only if solution is clear and seal intact.

45768F

Revised:  July 2008

PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 10  mL Single Dose Vial Label

NDC 63323-185-10

918510

Sterile Water for Injection, USP

FOR DRUG DILUENT USE ONLY

Rx only

10 mL  Single Dose Vial

STERILE WATER 
water injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63323-185
Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:63323-185-10 25 VIAL in 1 TRAY
1 10 mL in 1 VIAL
2 NDC:63323-185-50 25 VIAL in 1 TRAY
2 50 mL in 1 VIAL
3 NDC:63323-185-20 25 VIAL in 1 TRAY
3 20 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088400 09/05/2000
Labeler - Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 840771732 MANUFACTURE(63323-185)
Revised: 10/2014   Fresenius Kabi USA, LLC
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