FDA Label for Oxygen

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Oxygen Product Label

The following document was submitted to the FDA by the labeler of this product Encompass Medical & Specialty Gases, Ltd.. 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.

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OXYGEN, Compressed USP UN1072       OXYGEN 2         16639 (R 08/10)     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 use with 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 back flow preventive device in the piping. Close valve after each use and when empty. Cylinder temperature should not exceed 52 C (125F). Use in accordance with Material Safety Data Sheet (MSDS). CAS: 7782-44-7    RETURN WITH 25 PSIGDO NOT REMOVE THIS PRODUCT LABEL.Cylinders must be refilled by:Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109CONTENTS:  690 LTRS    CYL. SIZE E    TOP PSIG at 70 F    2015
REFRIGERATED LIQUIDOXYGEN, REFRIGERATED LIQUID USP UN1073       OXYGEN 2 ALWAYS KEEP CONTAINER IN UPRIGHT POSITION. DO NOT CHANGE OR FORCE FIT CONNECTIONS. CONTENTS: LTRS.     CU. FT. 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 use with oxygen. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. WARNING: EXTREMELY COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE . VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE.Keep oil, grease and combustibles away. Use only with equipment cleaned for oxygen. 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. Avoid spills. O not walk on or roll equipment over spills. Cylinder temperature should not exceed 52 C (125F).  Close valve after each use and when empty. Use a back flow preventive device in the piping. Use in accordance with Material Safety Data Sheet (MSDS). FIRST AID : IN CASE OF FROSTBITE, obtain medical treatment immediately. CAS: 7782-44-7    DO NOT REMOVE THIS PRODUCT LABEL.Cylinders must be refilled by:Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 6110947136 (R 10/05)
Produced by air liquefactionOXYGEN, Compressed U.S.P. UN1072       OXYGEN 2             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. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. WARNING: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. Use only with pressure reducing equipment and apparatus cleaned and designed for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty. Keep cylinder, cylinder valve, all equipment that connects, free of oil and grease to avoid violent ignition. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. Pursuant to recommendations by the Compressed Gas Association, do not expose pressurized cylinders to temperatures in excess of 125F. DO NOT REMOVE THIS PRODUCT LABEL.Use a back flow preventive device in the piping. Use only in accordance with product instructions and Material Safety Data Sheet. Cylinders must be refilled by:Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109CAS: 7782-44-7    RETURN WITH 25 PSIGDO NOT REMOVE THIS PRODUCT LABELCylinder contents at 70FCylinder sizeSize E 690 liters 2015 PSIGSize D 420 Liters 2015 PSIGSize M6 164 Liters 2015 PSIGSTORE AND USE WITH ADEQUATE VENTILATIONDate: 0810 Label:0035-647

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