Nitrogen Gas
FDA Label NDC 48546-0003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Indiana Oxygen Company Inc for the product Nitrogen (NDC 48546-0003). 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 nitrogen compressed label, nitrogen refrigerated liquid label, nitrogen certificate of analysis, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Nitrogen Compressed Label

NITROGEN COMPRESSED NF UN1066 CAS 7727-37-9 Rx ONLY 39251 (03/05) INDIANA OXYGEN COMPANY 6099 W. CORPORATE WAY INDIANAPOLIS, IN 46278 317-290-0003 CONTENTS H=6400 LTR, OTHER _________________

Nitrogen Refrigerated Liquid Label

NITROGEN REFRIGERATED LIQUID NF UN 1977 NON-FLAMMABLE GAS 2 ALWAYS KEEP CONTAINER IN UPRIGHT POSITION DO NOT CHANGE OR FORCE FIT CONNECTIONS. Rx ONLY INDIANA OXYGEN COMPANY 6099 W. CORPORATE WAY INDIANAPOLIS, IN 46278 317-290-0003 43549 (05/05)

Nitrogen Certificate Of Analysis

Certificate of Analysis - Nitrogen NF Customer ________________________ Vendor / Supplier _____________________________ This letter is to provide you with the certification you requested for Nitrogen NF, Lot number ___________. supplied to you in cylinders / vessels by our location. These cylinders were filled in accordance with the standard operating procedures utilized for the manufacture of Medical Gases. By following these procedures, our location ensures that products are safely manufactured in compliance with FDA's Current Good Manufacturing Regulations. CAUTION: Vendor supplies this certification to customer to assist customer in ensuring compliance with 21 CFR 211.84. This certification does not eliminate customer's obligation to cmply with other portions of 21 CFR 210 and 211 including but not limited to 21 CFR 211.165 (finished product testing) for cylinders and vessels filled from these supply cylinders. These cylinders are not certified for instrument calibration purposes.

TEST/REQUIREMENT         NF SPECIFICATION             LOT ANALYSIS
IDENTIFICATION                    PASS
ODOR                                    NO APPRECIABLE ODOR
OXYGEN                               LESS THAN 1.0%
CARBON MONOXIDE             LESS THAN 10 PPM
ASSAY                                  GREATER THAN 99.0%

THE METHODOLOGY BEING USED TO PERFORM THE NF TEST FOR ASSAY IS INDICATED BELOW:

________________________ PARAMAGNETIC ANALYZER MODEL NUMBER ___________________

________________________ ELECTROCHEMICAL ANALYZER MODEL NUMBER ______________

_______________________ GAS CHROMATOGRAPHY OFFICIAL USP / NF METHOD

SUPPLIER SIGNATURE ___________________ DATE _________________

J 700 a1 (01/03) BR COMPLIANCE ASSOCIATES LLC

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