Label: SODIUM CHLORIDE irrigant

  • NDC Code(s): 0338-0047-24, 0338-0047-27, 0338-0047-29
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 17, 2018

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  • DESCRIPTION

    0.9% Sodium Chloride Irrigation, USP is a sterile nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 9 g Sodium Chloride, USP (NaCl) in Water for Injection. pH 5.5 (4.5 to 7.0). Milliequivalents per liter: Sodium - 154, Chloride - 154. Osmolarity 308 mOsmol/L (calc.). No antimicrobial agent has been added.

    The ARTHROMATIC 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 can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

  • CLINICAL PHARMACOLOGY

    0.9% Sodium Chloride Irrigation, USP is useful as an irrigating fluid for body joints because the solution is isotonic, and provides a transparent fluid medium with optical properties suitable for good visualization of the interior joint surface during endoscopic examination. During arthroscopic surgical procedures, the solution acts as a lavage for removing blood, tissue fragments, and bone fragments.

  • INDICATIONS AND USAGE

    0.9% Sodium Chloride Irrigation, USP is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.

  • CONTRAINDICATIONS

    None known.

  • WARNINGS

    Not for injection.

    Because fluids used to irrigate joints may be absorbed into the general circulation, solutions containing sodium ion should be used with great care in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

    The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.

  • PRECAUTIONS

    Because some of the fluid used to irrigate joints may be absorbed, caution must be exercised in the volume of irrigating fluid used especially with solutions containing the sodium ion in patients receiving corticosteroids or corticotropin.

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

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

  • ADVERSE REACTIONS

    None known.

  • DOSAGE AND ADMINISTRATION

    The volume of solution needed will vary with the nature and duration of the arthroscopic procedure.

    If desired, warm in overpouch to near body temperature in a water bath or oven heated to not more than 45º C.

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

  • HOW SUPPLIED

    0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container is available as follows:

    2B7477

    3000 mL

    NDC 0338-0047-27

    2B7479

    5000 mL

    NDC 0338-0047-29

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

  • DIRECTIONS FOR USE

    Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port 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 bag firmly. If leaks are found, discard solution as sterility may be impaired.

    Use Aseptic Technique.

    1.
    Suspend container using hanger hole.
    2.
    Remove protector from outlet port.
    3.
    Attach irrigation set. Refer to complete directions accompanying set.

    Baxter Healthcare Corporation

    Deerfield, IL 60015 USA

    Printed in USA

    07-19-00-0407
    Rev. July 2018

    Baxter and Arthromatic are trademarks of Baxter International Inc.

  • PACKAGE LABEL.PRINCIPLE DISPLAY PANEL

    0.9% Sodium Chloride Irrigation USP Container Label

    0.9% Sodium Chloride Irrigation USP Container Label

    0.9% Sodium Chloride Irrigation USP Container Label

    NOT FOR INJECTION

    5000 mL

    2B7479

    NDC 0338-0047-29

    0.9% SODIUM CHLORIDE Irrigation USP

    EACH 100 mL CONTAINS 900 mg SODIUM

    CHLORIDE USP NO ANTIMICROBIAL AGENT HAS BEEN

    ADDED pH 5.5 (4.5 to 7.0) mEq/L SODIUM 154

    CHLORIDE 154 OSMOLARITY 308 mOsmol/L

    (CALC) STERILE NONPYROGENIC SINGLE DOSE

    CONTAINER

    DO NOT USE UNLESS SOLUTION IS CLEAR

    DISCARD UNUSED PORTION

    CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH

    MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS

    ARE FOUND RX ONLY STORE UNIT IN MOISTURE

    BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C)

    UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE

    INSERT

    0.9% Sodium Chloride NaCl Irrigation USP

    ARTHROMATIC CONTAINER PL 146 PLASTIC

    BAXTER HEALTHCARE CORPORATION

    DEERFIELD IL 60015 USA

    MADE IN USA

    BAXTER ARTHROMATIC AND

    PL 146 ARE TRADEMARKS OF

    BAXTER INTERNATIONAL INC

    FOR PRODUCT INFORMATION

    1-800-933-0303

    0.9% Sodium Chloride Irrigation USP Carton Label

    0.9% Sodium Chloride Irrigation USP Carton Label

    0.9% Sodium Chloride Irrigation USP Carton Label

    0.9% SODIUM CHLORIDE IRRIGATION, USP

    ARTHROMATIC CONT

    2-5000ML

    SECONDARY BAR CODE

    (17) YYMM00 (10) XXXXX

    PRIMARY BAR CODE

    (01) 50303380047296

    LOT XXXXX

    EXP XXXXX

    2B7479

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride irrigant
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0047
    Route of AdministrationIRRIGATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0047-2414 in 1 CARTON05/30/198012/22/2012
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:0338-0047-274 in 1 CARTON05/30/1980
    23000 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:0338-0047-292 in 1 CARTON05/30/1980
    35000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01786705/30/1980
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764ANALYSIS(0338-0047) , LABEL(0338-0047) , MANUFACTURE(0338-0047) , PACK(0338-0047) , STERILIZE(0338-0047)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502ANALYSIS(0338-0047)