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Carbon Dioxide Refrigerated Gas: Package Insert / Prescribing Info

Package insert / product label
Dosage form: gas

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Product Label
CARBON DIOXIDE REFRIGERATED
carbon dioxide gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52438-014
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:52438-014-2018770 L in 1 TANK; Type 0: Not a Combination Product01/01/1965
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20576401/01/1965
Labeler - Messer LLC (001368141)
Registrant - Messer LLC (001368141)
Establishment
NameAddressID/FEIBusiness Operations
Messer LLC833150639manufacture(52438-014) , api manufacture(52438-014)
Establishment
NameAddressID/FEIBusiness Operations
Messer LLC020153345manufacture(52438-014) , api manufacture(52438-014)
Establishment
NameAddressID/FEIBusiness Operations
Messer LLC004830011manufacture(52438-014) , api manufacture(52438-014)

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