FDA Label for Oxygen
View Indications, Usage & Precautions
Oxygen Product Label
The following document was submitted to the FDA by the labeler of this product Indiana Oxygen Company 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.
Oxygen Compressed Label
OXYGEN COMPRESSED USP
UN 1072
OXYGEN 2
(R-K14) 114619
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 in conjunction with resuscitative equipment. Produced by Air Liquefaction.
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight and when the ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
INDIANA OXYGEN COMPANY
6099 West Corporate Way, Indianapolis, IN 462278
317-290-0003
CONTENTS:
LTRS: _____ CU. FT. _____
OXYGEN COMPRESSED USP
UN 1072
OXYGEN 2
(R-K14) 114621
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 in conjunction with resuscitative equipment. Produced by Air Liquefaction.
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight and when the ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
INDIANA OXYGEN COMPANY
6099 West Corporate Way, Indianapolis, IN 462278
317-290-0003
CONTENTS:
LTRS: _____ CU. FT. _____
OXYGEN COMPRESSED USP
UN 1072
C.A.S. NO. 7782-44-7
Contents ______________________ LTRS. __________ CU. FT. __________
OXYGEN 2
(R-K14) 11623
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 in conjunction with resuscitative equipment. Produced by Air Liquefaction.
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight and when the ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. DO NOT REMOVE THIS PRODUCT LABEL.
INDIANA OXYGEN COMPANY
6099 West Corporate Way, Indianapolis, IN 462278
317-290-0003
OXYGEN COMPRESSED USP
UN 1072
C.A.S. NO. 7782-44-7
OXYGEN 2
(R-K14) 114919
INDIANA OXYGEN COMPANY
6099 West Corporate Way, Indianapolis, IN 462278
317-290-0003
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight and when the ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. DO NOT REMOVE THIS PRODUCT LABEL.
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 in conjunction with resuscitative equipment.
Produced by Air Liquefaction.
CYLINDER TYPE LITERS CYLINDER TYPE LITERS
R 570 M9 255
E 660 M6 170
D 400 Other ____________
Oxygen Refrigerated Label
REFRIGERATED LIQUID
OXYGEN,
REFRIGERATED
LIQUID
USP
UN 1073
OXYGEN 2
(R-K14) 115073
↑ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.↑
DO NOT CHANGE OR FORCE FIT CONNECTIONS.
CONTENTS: PG OXURM 164610
(LITERS) PG OX35OM 145522
WARNING:USP 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 in conjunction with resuscitative equipment.
Produced by Air Liquefaction.
DANGER: MAY CAUSE OR INTENFIFY FIRE: OXIDIZER.
CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY
COMBUSTIBLES IN CONTACT WITH LIQUIDE OXYGEN MAY EXPLODE ON IGNITION OT IMPACT.
Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield and eye protection. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the pping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. DO NOY change of force fit connections. Avoid spills. Do not walk or roll equipment over spills. Close valve after wach use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advise/attention.
CAS: 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL.
INDIANA OXYGEN COMPANY
6099 West Corporate Way, Indianapolis, IN 462278
317-290-0003
Oxygen Certificate Of Analysis
Certificate of Analysis - Oxygen USP
CUSTOMER ___________________ VENDOR / SUPPLIER ________________________
____________________________ Indiana Oxygen Co
____________________________ 6099 W Corporate Way
____________________________ Indianapolis, IN 46278
THIS LETTER IS TO PROVIDE YOU WITH THE CERTIFICATION YOU REQUESTED FOR OXYGEN USP 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 (cGMP) Regulations.
CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST CUSTOMER INENSURING COMPLIANCE WITH 21 CFR 211.84. THIS CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY WITHOTHER 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.
TEST REQUIREMENT USP SPECIFICATION LOT ANALYSIS
IDENTIFICATION PASS
ODOR PASS
CARBON DIOXIDE LESS THAT 0.03%
CARBON MONOXIDE LESS THAT 0.001%
ASSAY GREATER THAN 99.0%
* NOTE: The USP/NF exempts facilities that manufacture Oxygen USP by the Air Liquefaction process from the tests for Carbon Dioxide and Carbon Monoxide. As our label states, the Oxygen USP being supplied is manufactured by the Air Liquefaction Process.
The methodology being used to perform the USP / NF Test for Assay is indicated below:
Paramagnetic Analyzer Model # _________________________
Supplier Signature ___________________________ Date _____________
* Please review the disclaimer below.