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 Air Source Industries 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 B15
A AIR SOURCE INDUSTRIES, INC.
3976 CHERRY AVE., LONG BEACH, CA 90807
In (CA) (800) 295-4271 (562) 426-4017
OXYGEN 2 AS - 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. 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 piping. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.
CAS: 7782-44-7 DO NOT REMOVE TIS PRODUCT LABEL
Oxygen Refrigerated Liquid Label
Oxygen, Refrigerated Liquid, USP
UN 1073 Rx ONLY
A AIR SOURCE INDUSTRIES, INC.
3976 CHERRY AVE., LONG BEACH, CA 90807
In (CA) (800) 295-4271 (562) 426-4017
OXYGEN 2
D15 AS-16
Rx ONLY. 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. Produced by Air Liquefaction.
DANGER: MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. CONTAINS REFRIGERATED GAS. MAY CAUSE CRYOGENIC BURNS OR INJURY: COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR 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 piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Do not change or force fit connections. Avoid spills. Do not walk or roll equipment over spills. Close valve after each 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 TIS PRODUCT LABEL
Oxygen Certificate Of Analysis
CUSTOMER ___________________ VENDOR / SUPPLIER ________________________ THIS LETTER IS TO PROVIDE YOU WITH THE
CERTIFICATION YOU REQUESTED FOR OXYGEN USP 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
Practices
(cGMP) Regulations.
CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST
CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84. THIS
CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY 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.
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 # _________________________
J 700 a1
REVISION 1.0
CERTIFICATE OF ANALYSIS - OXYGEN USP
* Please review the disclaimer below.