Label: STERILE WATER- water injection

  • NDC Code(s): 0409-4887-05, 0409-4887-10, 0409-4887-17, 0409-4887-20, view more
    0409-4887-23, 0409-4887-24, 0409-4887-25, 0409-4887-31, 0409-4887-32, 0409-4887-34, 0409-4887-50, 0409-4887-99
  • Packager: Hospira, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 20, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Glass Vial
    Plastic Vial

  • DESCRIPTION

    This preparation is designed solely for parenteral use only after addition of 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 I.V. injection, add sufficient solute to make an approximately isotonic solution.

    Water for Injection, USP is chemically designated H2O.

    The glass vial is Type I or II borosilicate glass and meets the requirements of the powdered glass test according to the USP standards.

    The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume.

  • CLINICAL PHARMACOLOGY

    Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

    Water balance is maintained by various regulatory mechanisms. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

    The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants.

  • INDICATIONS AND USAGE

    This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

  • CONTRAINDICATIONS

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

  • WARNINGS

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

  • PRECAUTIONS

    Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.

    Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.

    Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.

    Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.

    Pediatric Use

    Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

    Drug Interactions

    Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.

    Use aseptic technique for single or multiple entry and withdrawal from all containers.

    When diluting or dissolving drugs, mix thoroughly and use promptly.

    Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

    Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion.

  • 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.

  • OVERDOSAGE

    Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

  • DOSAGE AND ADMINISTRATION

    The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

    This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  • HOW SUPPLIED

    Sterile Water for Injection, USP is supplied in the following:

    Unit of SaleTotal Content
    NDC 0409-4887-05
    Tray of 25 Single-dose Glass Fliptop Vials
    1 mL
    NDC 0409-4887-10
    Tray of 25 Single-dose Plastic Fliptop Vials
    10 mL
    NDC 0409-4887-34
    Tray of 30 Single-dose Plastic Fliptop Vials
    10 mL
    NDC 0409-4887-20
    Tray of 25 Single-dose Plastic Fliptop Vials
    20 mL
    NDC 0409-4887-50
    Tray of 25 Single-dose Plastic Fliptop Vials
    50 mL
    NDC 0409-4887-99
    Case of 25 Single-dose Glass Fliptop Vials
    100 mL

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

    Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

                                                                                      Hospira logo

    LAB-1292-2.0

    Revised: 05/2021

  • PRINCIPAL DISPLAY PANEL - 100 mL Vial Label

    100 mL
    Single-dose

    WARNINGS: NOT ISOTONIC. HEMOLYTIC.

    Sterile Water
    For Inj., USP

    FOR DRUG DILUENT USE ONLY

    Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

    LOT ##-###-AA
    EXP DMMMYYYY

    PRINCIPAL DISPLAY PANEL - 100 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 1 mL Vial Label

    1 mL Fill Single-dose

    Sterile Water
    for Injection,
    USP

    Rx only

    Hospira

    Hospira, Inc., Lake Forest, IL 60045 USA

    PRINCIPAL DISPLAY PANEL - 1 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-17

    10 mL Single-dose

    Sterile Water
    for Injection, USP

    FOR DRUG DILUENT USE

    LOT ##-###-AA
    EXP DMMMYYYY

    PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-17
  • PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-10

    10 mL Single-dose

    Rx only
    NDC 0409-4887-10
    Contains 25 of NDC 0409-4887-17

    Sterile Water for Injection, USP

    FOR DRUG DILUENT USE

    Hospira

    PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-10
  • PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-32

    10 mL Single-dose

    Sterile Water
    for Inj., USP

    Rx only

    Hospira

    LOT ##-###-AA
    EXP DMMMYYYY

    PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-32
  • PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-34

    10 mL Single-dose

    Rx only

    NDC 0409-4887-34
    Contains 30 of NDC 0409-4887-32

    Sterile Water for Injection, USP

    FOR DRUG DILUENT USE

    Hospira

    PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-34
  • PRINCIPAL DISPLAY PANEL - 20 mL Vial Label

    20 mL Single-dose

    Sterile Water
    for Injection, USP

    FOR DRUG DILUENT USE

    LOT ##-###-AA
    EXP DMMMYYYY

    PRINCIPAL DISPLAY PANEL - 20 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray

    20 mL Single-dose

    Rx only
    NDC 0409-4887-20
    Contains 25 of NDC 0409-4887-23

    Sterile Water for Injection, USP

    FOR DRUG DILUENT USE

    Hospira

    PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray
  • PRINCIPAL DISPLAY PANEL - 50 mL Vial Label

    50 mL Single-dose

    Sterile Water
    for Injection, USP

    FOR DRUG DILUENT USE

    LOT ##-###-AA
    EXP DMMMYYYY

    PRINCIPAL DISPLAY PANEL - 50 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray

    50 mL Single-dose

    Rx only
    NDC 0409-4887-50
    Contains 25 of NDC 0409-4887-24

    Sterile Water for Injection, USP

    FOR DRUG DILUENT USE

    Hospira

    PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray
  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    water injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0409-4887
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    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:0409-4887-9925 in 1 CASE08/03/2005
    1NDC:0409-4887-25100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    2NDC:0409-4887-0525 in 1 TRAY01/31/201105/01/2013
    2NDC:0409-4887-311 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    3NDC:0409-4887-1025 in 1 TRAY08/01/2005
    3NDC:0409-4887-1710 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    4NDC:0409-4887-3430 in 1 TRAY07/30/2015
    4NDC:0409-4887-3210 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    5NDC:0409-4887-2025 in 1 TRAY06/16/2005
    5NDC:0409-4887-2320 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    6NDC:0409-4887-5025 in 1 TRAY08/04/2005
    6NDC:0409-4887-2450 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01880106/16/2005
    Labeler - Hospira, Inc. (141588017)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hospira, Inc.093132819ANALYSIS(0409-4887) , MANUFACTURE(0409-4887) , PACK(0409-4887) , LABEL(0409-4887)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hospira, Inc.827731089ANALYSIS(0409-4887)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Healthcare India Private Limited860037912ANALYSIS(0409-4887) , MANUFACTURE(0409-4887) , PACK(0409-4887) , LABEL(0409-4887)