Label: STERILE WATER- water irrigant

  • NDC Code(s): 0264-2101-00, 0264-2101-10, 0264-2101-50, 0264-2101-70
  • Packager: B. Braun Medical Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 7, 2019

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

  • DESCRIPTION

    Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0–7.0)

    The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests—Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

    The PIC™ Container is PVC-free and DEHP-free.

  • CLINICAL PHARMACOLOGY

    Sterile Water for Irrigation USP is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures. It is also utilized as a pharmaceutic aid, as well as in the preparation of enteral nutrient products.

    Water is hypotonic and will cause hemolysis and will be readily absorbed by the tissues during surgical procedures; therefore, its use under such conditions is not recommended.

  • INDICATIONS AND USAGE

    Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION).

  • CONTRAINDICATIONS

    Not for injection.

  • WARNINGS

    Sterile Water for Irrigation USP is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures.

    After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

    Discard unused portion of irrigating solution since it contains no preservative.

  • PRECAUTIONS

    Use only if solution is clear and container and seal are intact.

  • ADVERSE REACTIONS

    None known.

  • OVERDOSAGE

    None known.

  • DOSAGE AND ADMINISTRATION

    Irrigation

    Use as directed by physician.

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

    Nutrient Mixtures

    Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures. It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.

  • HOW SUPPLIED

    Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in plastic irrigating containers. The 1000 mL and 500 mL containers are packaged 16 per case; the 2000 mL are packaged 8 per case and the 4000 mL are packaged 4 per case.

    NDC Cat. No. Size
     Sterile Water for Irrigation USP
    (Canada DIN 01963961)
      
     0264-2101-00 R5000-01 1000 mL
     0264-2101-10 R5001-01 500 mL
     0264-2101-50 R5005-01 2000 mL
     0264-2101-70 R5007 4000 mL

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

    Do not warm above 150°F (66°C).

  • SPL UNCLASSIFIED SECTION

    Rx only

    Revised: March 2009

    PIC is a trademark of B. Braun Medical Inc.

  • Directions For Use

    Aseptic technique is required.

    1. Caution – Before use, perform the following checks:
      (a) Read the label. Ensure solution is the one ordered and is within the expiration date.
      (b) Invert container and inspect the solution in good light for cloudiness, haze or particulate matter; check the container for  
            leakage or damage. Any container which is suspect should not be used.

      Use only if solution is clear and container and seal are intact.

      Single unit container.
      Discard unused portion.
      Not for injection.
    2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off.
      Figure 1
    3. Connect the administration set through the sterile set port according to set instructions or remove screw cap and pour. 
      Figure 2
       
    4. Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.
  • SPL UNCLASSIFIED SECTION

    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    In Canada, distributed by:
    B. Braun Medical Inc.
    Scarborough, Ontario M1H 2W4

    Y36-002-701

  • PRINCIPAL DISPLAY PANEL - 1000 mL Container

    Sterile Water for
    Irrigation USP

    Warnings: Hypotonic and Hemolytic

    Lot
    Exp.

    REF R5000-01
    NDC 0264-2101-00
    DIN 01963961
    HK 23675

    1000 mL

    Y37-002-319

    No antimicrobial agent or other
    substance has been added.

    pH: 5.7 (5.0-7.0)

    Not for Injection.
    See Package Insert.
    Use only if solution is clear and
    container and seal are intact.

    Sterile, nonpyrogenic. Single unit
    container. Discard unused portion.

    Warning: Do not warm above
    150°F (66°C).

    Recommended Storage:
    Room temperature (25°C).
    Avoid excessive heat. Protect
    from freezing. See Package Insert.

    Rx only

    PVC-free and DEHP-free

    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    In Canada, distributed by:
    B. Braun Medical Inc.
    Scarborough, Ontario M1H 2W4

    1000 mL Container Label R5000-01
  • PRINCIPAL DISPLAY PANEL - 500 mL Container

    Sterile Water for
    Irrigation USP

    Warnings: Hypotonic and Hemolytic

    Lot
    Exp.

    REF R5001-01
    NDC 0264-2101-10
    DIN 01963961
    HK 23675

    500 mL

    Y37-002-321

    No antimicrobial agent or other
    substance has been added.

    pH: 5.7 (5.0-7.0)

    Not for Injection.
    See Package Insert.
    Use only if solution is clear and
    container and seal are intact.

    Sterile, nonpyrogenic. Single unit
    container. Discard unused portion.

    Warning: Do not warm above
    150°F (66°C).

    Recommended Storage:
    Room temperature (25°C).
    Avoid excessive heat. Protect
    from freezing. See Package Insert.

    Rx only

    PVC-free and DEHP-free

    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    In Canada, distributed by:
    B. Braun Medical Inc.
    Scarborough, Ontario M1H 2W4

    500 mL Container Label R5001-01
  • PRINCIPAL DISPLAY PANEL - 2000 mL Container

    Sterile Water for
    Irrigation USP

    Warnings: Hypotonic and Hemolytic

    Lot
    Exp.

    REF R5005-01
    NDC 0264-2101-50
    DIN 01963961
    HK 23675

    2000 mL

    Y37-002-322

    No antimicrobial agent or other
    substance has been added.

    pH: 5.7 (5.0-7.0)

    Not for Injection.
    See Package Insert.
    Use only if solution is clear and
    container and seal are intact.

    Sterile, nonpyrogenic. Single unit
    container. Discard unused portion.

    Warning: Do not warm above
    150°F (66°C).

    Recommended Storage:
    Room temperature (25°C).
    Avoid excessive heat. Protect
    from freezing. See Package Insert.

    Rx only

    PVC-free and DEHP-free

    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    In Canada, distributed by:
    B. Braun Medical Inc.
    Scarborough, Ontario M1H 2W4

    2000 mL Container Label R5005-01
  • PRINCIPAL DISPLAY PANEL - 4000 mL Container

    Sterile Water for
    Irrigation USP

    Warnings: Hypotonic and Hemolytic

    Lot
    Exp.

    REF R5007
    NDC 0264-2101-70
    DIN 01963961
    HK 23675

    4000 mL

    Y37-002-351

    No antimicrobial agent or other
    substance has been added.

    pH: 5.7 (5.0-7.0)

    Not for Injection.
    See Package Insert.
    Use only if solution is clear and
    container and seal are intact.

    Sterile, nonpyrogenic. Single unit
    container. Discard unused portion.

    Warning: Do not warm above
    150°F (66°C).

    Recommended Storage:
    Room temperature (25°C).
    Avoid excessive heat. Protect
    from freezing. See Package Insert.

    Rx only

    PVC-free and DEHP-free

    B. Braun Medical Inc.
    Irvine, CA 92614-5895 USA
    Made in USA

    In Canada, distributed by:
    B. Braun Medical Inc.
    Scarborough, Ontario M1H 2W4

    4000 mL Container Label R5007
  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    water irrigant
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-2101
    Route of AdministrationIRRIGATION
    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:0264-2101-0016 in 1 CASE09/10/1970
    11000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0264-2101-1016 in 1 CASE09/10/1970
    2500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:0264-2101-508 in 1 CASE09/10/1970
    32000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    4NDC:0264-2101-704 in 1 CASE09/10/1970
    44000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01673409/10/1970
    Labeler - B. Braun Medical Inc. (002397347)