Label: SODIUM CHLORIDE irrigant

  • NDC Code(s): 0338-0047-44, 0338-0047-46, 0338-0047-47
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 4, 2017

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  • SPL UNCLASSIFIED SECTION

    Directions for Use of Flexible Plastic Irrigation Containers

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

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

  • 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 plastic protector from outlet port at bottom of container.
    3.
    Attach irrigation set. Refer to complete directions accompanying set.

    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.

  • SPL UNCLASSIFIED SECTION

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Printed in Mexico

    ©Copyright 1980, 1984, 1989, Baxter Healthcare Corporation.
    All rights reserved.

    Rev. May 2017

    88-80-31-833

  • PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

    Representative Container Label 0338-0047-44

    3000 mL
    2B77127
    NDC 0338-0047-47

    NOT FOR INJECTION

    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

    UROMATIC container

    PL 146 plastic

    BAXTER UROMATIC and PL 146 are
    trademarks of Baxter International Inc

    For product information
    1-800-933-0303

    Baxter Logo
    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Made in Mexico

    2700

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    Sodium Chloride Representative Carton Label

    2B7127
    4-3000 ML

    VIAFLEX® CONTAINER

    0.9% SODIUM CHLORIDE
    IRRIGATION, USP

    EXP
    BAR CODE
    ( 17 ) 180400 ( 10 ) V16028A

    LOT
    BAR CODE
    (01) 50303380047470

  • 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:0338-0047-4414 in 1 CARTON05/30/1980
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:0338-0047-466 in 1 CARTON05/30/1980
    22000 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:0338-0047-474 in 1 CARTON05/30/1980
    33000 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter, S.A. de C.V.810432484ANALYSIS(0338-0047) , MANUFACTURE(0338-0047) , LABEL(0338-0047) , PACK(0338-0047) , STERILIZE(0338-0047)