Carbon Dioxide Gas
FDA Label NDC 52374-103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Messer Gas Puerto Rico, Inc for the product Carbon Dioxide (NDC 52374-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

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