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 Respiratory Care Partners, 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
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 PREVENTATIVE DEVICE IN PIPING. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. CYLINDER TEMPERATURES SHOULD NOT EXCEED 52 C (125 F) USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS) DO NOT REMOVE PRODUCT LABEL
CAS 7782-44-7 17030 (08/07)
CONTENTS________________________________
Oxygen Refrigerated Liquid Label
OXYGEN REFRIGERATED LIQUID U.S.P. UN 1073
GROSS WT. __________LBS _______OZ
NET WT. _________LBS __________OZ
SIZE _______ CONTENTS ___________ LITERS ______________
Rx ONLY. OXYGEN PRODUCED BY AIR LIQUEFACTION 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.
WARNING: DO NOT GET LIQUID IN EYES ON SKIN OR CLOTHING. DO NOT DROP. USE HAND TRUCK SPECIFICALLY DESIGNED FOR LIQUID CYLINDER MOVEMENT. AVOID SPILLS. DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. USE IN ACCORDANCE WITH BOC GASES MSDS G-102
IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.
TO BE REFILLED BY A BOC GASES AUTHORIZED FACILITY ONLY.
CAS 7782-44-7 AIRCO DO NOT REMOVE PRODUCT LABEL MG 1644E LSP 6004E 5/98
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.