Label: STERILE WATER irrigant

  • NDC Code(s): 0264-7386-50, 0264-7386-60
  • Packager: B. Braun Medical Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 16, 2020

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 made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

    Not made with natural rubber latex, PVC or DEHP.

  • 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 single-dose 2000 and 3000 mL flexible irrigation containers packaged 4 per case.

     NDC REF SIZE
     0264-7386-50    R8005    2000 mL
     0264-7386-60 R8006 3000 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.

  • Directions for Use of Plastic Container

    Not for injection.

    Not for use with pressurized irrigation systems.

    Aseptic technique is required.

    Tear Notches. Overwrap Illustration.
    • Inspect irrigation bag: overwrap and primary bag.
    • Do not use if overwrap has been damaged.
    • Do not use unless solution is clear and closure is intact.
    1. To open: Tear overwrap starting from the tear notches. (Figure 1) 
      Tear Overwrap Illustration

       
    2. Prepare medication port by removal of aluminum foil. (Figure 2a)
      • Puncture resealable medication port by using 19 – 22 gauge needle and inject additive(s). (Figure 2b)
        Illustration 2
      • Mix solution and medication thoroughly. (Figure 3a)
      • Medication port must be swabbed with disinfection agent before re-puncturing.
      • Check admixture visually for particulate matter. (Figure 3b)
        Illustration 3
    3. Remove aluminum foil from outlet/set port at the bottom of container (Figure 4a) and attach administration set (Figure 4b): use non-vented infusion set or close air vent on a vented set. Refer to directions for use accompanying the administration set.
      Illustration 4
    4. Hang bag on IV Pole. (Figure 5)
      Illustration 5
  • SPL UNCLASSIFIED SECTION

    Rx only

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    LD-401-5 Y36-002-984

    Revised: August 2018

  • PRINCIPAL DISPLAY PANEL

    Sterile Water
    for
    IRRIGATION,
    USP

    INDICATIONS: FOR IRRIGATION

    CONTRAINDICATIONS:
    NOT FOR INJECTION

    REF  R8005
    NDC  0264-7386-50

    LOT
    EXP.

    2000 mL

    No antimicrobial agent or other
    substance has been added.

    pH: 5.7 (5.0-7.0)

    WARNINGS: HYPOTONIC AND HEMOLYTIC

    See Package Insert.

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

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

    Dosage: Irrigation. Use as directed by physician.

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

    Rx only

    Not made with natural
    rubber latex, PVC or DEHP.

    Recycle 7 Symbol

     SET

    set arrow illustration 

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y38-000-049     LD-255-5

    2000 mL container label R8005
  • PRINCIPAL DISPLAY PANEL

    Sterile Water
    for IRRIGATION,
    USP

    INDICATIONS: FOR IRRIGATION

    CONTRAINDICATIONS:
    NOT FOR INJECTION

    REF  R8006
    NDC  0264-7386-60

    LOT
    EXP.

    3000 mL

    No antimicrobial agent or
    other substance has been added.

    pH: 5.7 (5.0-7.0)

    WARNINGS: HYPOTONIC AND HEMOLYTIC

    See Package Insert.

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

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

    Dosage: Irrigation. Use as directed by physician.

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

    Rx only

    Not made with natural
    rubber latex, PVC or DEHP.

    Recycle 7 Symbol

    SET

    set arrow illustration

    B. Braun Medical Inc.
    ​​​​​Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y38-000-050     LD-256-5

    3000 mL container label R8006
  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    sterile water irrigant
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-7386
    Route of AdministrationIRRIGATION
    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:0264-7386-504 in 1 CASE09/13/2013
    12000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0264-7386-604 in 1 CASE09/13/2013
    23000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01673409/13/2013
    Labeler - B. Braun Medical Inc. (002397347)