FDA Label for Oxygen Compressed

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Oxygen Compressed Product Label

The following document was submitted to the FDA by the labeler of this product Monroe Welding Supply, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.Principal Display Panel



OXYGEN, COMPRESSED USP
UN 1072

WARNING:  For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.  For all other medical applications, Rx only.  Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful.  Use only with pressure reducing equipment and apparatus designed for oxygen.  Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.  Produced by Air Liquefaction.  WARNING: HIGH PRESSURE OXIDIZING GAS.  VIGOROUSLY ACCELERATES COMBUSTION.  Keep oil and grease away.  Open valve slowly.  Store and use with adequate ventilation.  Use only with equipment cleaned for Oxygen service and rated for cylinder pressure.  Use a backflow preventive device in the piping.  Close valve after each use and when empty.  Cylinder temperature should not exceed 52oC (125oF).  Use in accordance with the Material Safety Data Sheet (MSDS).

CAS:7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL
17033  (R 04/05)

MONROE WELDING SUPPLY, INC.
410 N 18TH STREET   MONROE, LA  71201
318-387-3731   1-800-854-4239

CONTENTS:  LTRS.______   CU.FT. ______


Oxygen, Certificate Of Analysis




CERTIFICATE OF ANALYSIS  Facility No.  Rev. 03-01-03
Product: Oxygen, USP   Monroe Welding Supply, Inc.  410 North 18th Street  Monroe, LA  71210
Serial No.__________
Lot No. __________
Manufacture: Produced by Air Liquefaction
Bulk storage vessel   Vehicle-mounted vessel   DOT 4L portable cylinder   Home cryogenic vessel   High-pressure cylinder
ANALYZE   SPECIFICATION   RESULTS   ANALYTICAL METHOD   ANALYZER
Odor   None   _____   Olfaction (smell)
ID   Oxygen   _____   Paramagnetic Oxygen analyzer
Assay   >99.2   _____
Analyst   __________   Date:_____
“This is to certify that I have been trained in the vendor’s analytical methodology and have witnessed the analysis of this lot of drug product”
Witnessed: __________ (Customer representative)   Date: _____
Company:__________
Remarks:


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