Nitrogen Gas
FDA Label NDC 54218-600

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United States Welding, Inc. for the product Nitrogen (NDC 54218-600). 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 nf refrigerated liquid label, general warnings and precautions, nitrogen certificate of analysis, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Nitrogen Nf Refrigerated Liquid Label

NITROGEN REFRIGERATED LIQUID

NF

UN 1977

NON-FLAMMABLE GAS - 2

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.

CONTENTS:______________________________________

LOT NUMBER: ____________________________________

Rx ONLY

WARNING: EXTREMELY COLD LIQUID AND GAS UNDER PRESSURE  CAN CAUSE RAPID SUFFOCATION.  CAN CAUSE SEVERE FROSTBITE.

Store and use with adequate ventilation.

Do not get liquid in eyes, on skin or clothing

For liquid withdrawal, wear face shield and gloves

Do not Drop. Use suitable hand truck for container movement.  Container temperature should not exceed 52 C (125 F)  Close valve after each use and when empty.  Use in accordance with the Material Safety Data Sheet (MSDS)  USW 1001 Rev 6-08

General Warnings And Precautions

WARNING: Administration of Nitrogen may be hazardous or contraindicated.  For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Nitrogen and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.

FIRST AID: If inhaled, remove to fresh air.  If not breathing, give artificial respiration.  If breathing is difficult, give oxygen, call a physician.

DO NOT REMOVE THIS PRODUCT LABEL

Nitrogen Certificate Of Analysis

This letter is to provide you with the Certification you requested for Nitrogen NF, Lot #_________________________  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 Practices Regulations
                
            Caution: Vendor supplies this certification to customer to assist customer in ensureing compliance with 21 CFR 211.84.  This certification does not eliminate customer's obligation
            to comply with other portions of 21 CFR 210 and 211 including but not limited to 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 or equal to 1.0%      ___________________

Carbon Monoxide    Less than or equal to 10 ppm   ___________________

Assay                  Greater than or equal to 99.0%   ______________________

The methodology being used to perform the NF Test for Assay is indicated below:

______________________________ Paramagnetic Analyzer ___________________ Model #

_____________________________  Electrochemical Analyzer __________________ Model #

Gas Chromatography Official USP / NF Method ________________________________

Supplier Signature _____________________________________  Date ________________________Enter section text here

Package Label.Principal Display Panel

Rx ONLY

CAUTION: High pressure gas.  Can cause rapid suffocation.  Store and use with adequate ventilation.  Use equipment rated for cylinder pressure.  Cylinder temperature should not exceed 52 C (125 F).  Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). 

Do Not Remove This Product Label

CAS 7727-37-9

NITROGEN COMPRESSED NF UN 1066

33049 (05/01)

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