Label: CARBON DIOXIDE- carbon dioxide gas

  • NDC Code(s): 45149-014-01
  • Packager: Messer Merchant Production LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 2, 2021

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    CO2 USP CoA

    BULK CARBON DIOXIDE USP CERTIFICATE OF ANALYSIS

    This is to certify that the carbon dioxide produced at ______________________ on ______________________ meets the United States Pharmacopeia (USP) specifications, the requirements of Federal Specifications BB-C-101 Grade A and QVL E of CGA G6.2. This product was manufactured at a facility registered with the Federal Food and Drug Administration and is approved for prescription drug use. This product is not guaranteed to meet any other specification or intended for pesticide use.


    Furthermore, batch number ______________________ and lot number ______________________, which was loaded on ______________________and filled at ______________________, comprises this shipment and was analyzed as shown below.


    Analytical results are generated using USP monograph or validated equivalent methods.

    RequirementTest MethodLimit of DetectionSpecification LimitAnalysis Results
    Carbon Dioxide Assay (CO2)Zahm Nagel99.00%≥ 99.0%
    Nitrogen Oxides (NOx)Detector Tube0.5 ppm2.5 ppm each
    Ammonia (NH3)Detector Tube0.25 ppm25 ppm
    Total SulfurAnalyzer10 ppb1000 ppb
    Carbon Monoxide (CO)Detector Tube0.5 ppm10 ppm
    Moisture (H2O)Analyzer0.5 ppm200 ppm or -33°F Dew Point

    Note:
    1) Positive Carbon Dioxide Identification is achieved when the Assay results demonstrate meeting the specification.
    2) The limit of detection (LOD) for each test method is the threshold value for results to be reported with certainty in the accuracy of results. A test result outside the detection limit for the test method will be reported as ND.
    3) ND=None Detected
    4)ppm= parts per million by volume, ppb=parts per billion by volume, 1ppm=1,000 ppb
    5) H2S, SO2, and other sulfur species are included in the total sulfur amount

    Product analyzed using Messer Premier Guard Analysis suite


    Analyst____________________________________________  Date: __________________________________



    Reviewed and released by:____________________________  Date: __________________________________



    _______________________________________________________________________

    March 2019
    CO2-22-06-RNA-Medical Gas USP Procedures
    Page 1 of 1
    Retention Period - 3 years

  • INGREDIENTS AND APPEARANCE
    CARBON DIOXIDE  
    carbon dioxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:45149-014
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carbon Dioxide (UNII: 142M471B3J) (Carbon Dioxide - UNII:142M471B3J) Carbon Dioxide990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45149-014-0118770 L in 1 TANK; Type 0: Not a Combination Product01/01/1965
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20581501/01/1965
    Labeler - Messer Merchant Production LLC (809567303)
    Registrant - Messer Merchant Production LLC (831800201)
    Establishment
    NameAddressID/FEIBusiness Operations
    Messer Merchant Production LLC831800201manufacture(45149-014) , api manufacture(45149-014)