Label: STERILE WATER- water injection, solution

  • NDC Code(s): 0338-0013-04
  • Packager: Baxter Healthcare Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 29, 2019

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  • DESCRIPTION

    Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0). The osmolarity is 0.

    The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

  • CLINICAL PHARMACOLOGY

    Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable medications.

  • INDICATIONS AND USAGE

    Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.

  • CONTRAINDICATIONS

    Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without additives.

  • WARNINGS

    Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute.

    Hemolysis may occur following infusion of Sterile Water for Injection, USP.  Hemoglobin induced renal failure has been reported following hemolysis.

  • PRECAUTIONS

    Do not administer unless solution is clear and seal is intact.

  • ADVERSE REACTIONS

    The administration of a suitable admixture of prescribed additives may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

  • DOSAGE AND ADMINISTRATION

    Following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying additive drug.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

    Injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

    Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Do not store an unused portion of Sterile Water for Injection, USP. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

  • HOW SUPPLIED

    Sterile Water for Injection, USP is supplied in VIAFLEX plastic containers as follows:

    1000 mL

    2B0304

    NDC 0338-0013-04

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

  • DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER

    Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

    To Open

    Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the port outlet protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. See following directions.

    Preparation for Administration After Rendering Isotonic

    1.
    Suspend container from eyelet support.
    2.
    Remove plastic protector from outlet port at bottom of container.
    3.
    Attach administration set. Refer to complete directions accompanying set.

    Warning: Additives may be incompatible.

    To add medication before administration

    1.
    Prepare medication site.
    2.
    Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    3.
    Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

    To add medication during administration

    1.
    Close clamp on the set.
    2.
    Prepare medication site.
    3.
    Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    4.
    Remove container from IV pole and/or turn to an upright position.
    5.
    Evacuate both ports by squeezing them while container is in the upright position.
    6.
    Mix solution and medication thoroughly.
    7.
    Return container to in use position and continue administration.

    Baxter Healthcare Corporation

    Deerfield, IL 60015 USA

    Printed in USA

    07 19 73 675

    Rev. September 2014

    Baxter, Viaflex, and PL 146 are trademarks of Baxter International Inc.

  • PACKAGE LABEL.PRINCIPLE DISPLAY PANEL

    Sterile Water Container Label NDC 0338-0013-04

    Sterile Water Container Label

    Sterile Water Container Label

    LOT EXP

    2B0304

    NDC 0338-0013-04

    STERILE WATER

    STERILE WATER FOR INJECTION USP

    FOR DRUG DILUENT USE ONLY

    1000mL

    NO ANTIMICROBIAL OR OTHER SUBSTANCE HAS BEEN ADDED

    pH 5.5 (5.0 TO 7.0) STERILE NONPYROGENIC SINGLE

    DOSE CONTAINER ADMINISTER INTRAVENOUSLY ONLY AFTER

    RENDERING APPROXIMATELY ISOTONIC WITH SUITABLE SOLUTE

    ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST

    IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC

    TECHNIQUE MIX THOROUGHLY DO NO STORE DOSAGE

    INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE

    DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG

    WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE

    FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT

    USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN

    MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C)

    UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT

    VIAFLEX PLUS CONTAINER PL 146 PLASTIC

    BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF

    BAXTER INTERNATIONAL INC

    FOR PRODUCT INFORMATION 1-800-933-0303

    BAXTER

    BAXTER HEALTHCARE CORPORATION

    DEERFIELD IL 60015 USA

    MADE IN THE USA

    Sterile Water Carton Label NDC 0338-0013-04

    Sterile Water Carton Label

    Sterile Water Carton Label

    2B0304X 14-1000 ML UNITS

    VIAFLEX® CONTAINER

    STERILE WATER FOR INJ., USP

    EXP

    XXXXX

    SECONDARY BAR CODE

    (17) XXXXX (10) XXXXX

    LOT

    XXXXX

    PRIMARY BAR CODE

    (01) 50303380013048

    NOTE: Lot and Exp. Date added at time of printing.

    Secondary bar code human readable is variable and will be

    added at time of printing. The parenthesis are not

    encoded in actual bar code.

  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    water injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0013
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER100 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0013-041000 mL in 1 BAG; Type 0: Not a Combination Product06/30/1982
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01863206/30/1982
    Labeler - Baxter Healthcare Company (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764API MANUFACTURE(0338-0013) , ANALYSIS(0338-0013) , LABEL(0338-0013) , MANUFACTURE(0338-0013) , PACK(0338-0013) , STERILIZE(0338-0013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502ANALYSIS(0338-0013)