Warnings And Precautions Section
Should the material not be delivered to a USP customer, the material is “Not Approved for Human Drug Use.”
Oxygen Gas
FDA Label NDC 52003-011
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 Canada Inc. for the product Oxygen (NDC 52003-011). 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 warnings and precautions section, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Package Label.Principal Display Panel
Linde
Certicate of Analysis - Oxygen USP
Product: Oxygen USP
Date |
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Facility Name |
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Facility Address |
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Lot# |
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Final Analysis Results
Analyzer # | Test/Units | USP Specs | Analysis Results |
N/A | Odor | None |
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| % O2 | > 99.0% | % |
| ppm H2O | N/A | ppm |
| ppm THC | N/A | ppm |
N/A | % CO | ≤ .001 | *** |
N/A | % CO2 | ≤ .03 | *** |
NT= not tested
*** = This product was manufactured by Air Liquefaction and testing is exempt under the USP compendium.
The methodology used to perform the USP test:
Paramagnetic Analyzer Manufacturer / Model# : _______________________________________________
This analyzer has been validated by Linde as acceptable alternatives to the official USP for Oxygen Assay. Validation study documentation is maintained at the Linde Corporate Offices.
Analyst | Date |
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Quality Reviewer | Date |
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Should the material not be delivered to a USP customer, the material is “Not Approved for Human Drug Use.”
2.4 October 2017
ASU-22-06-GAM-Medical Gas Procedures
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Retention Period – 3 Years
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