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OXYGEN

Indiana Oxygen Company, Inc.
Indiana Oxygen Company, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP UN 1072 PRODUCED BY AIR LIQUEFACTION. 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 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. 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 THE PIPING. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F) USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS) CAS 7782-44-7 RETURN WITH 25 PSIG DO NOT REMOVE THIS LABEL PRODUCED BY AIR LIQUEFACTION CONTENTS T=8620 LTR, H=6900 LTR, G=5300 LTR, M=3110 LTR 19210 (03/05) INDIANA OXYGEN COMPANY 6099 W. CORPORATE WAY INDIANAPOLIS, IN 46278 317-290-0003

OXYGEN

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP UN 1072 PRODUCED BY AIR LIQUEFACTION. 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 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. 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 THE PIPING. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F) USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS) CAS 7782-44-7 RETURN WITH 25 PSIG DO NOT REMOVE THIS LABEL PRODUCED BY AIR LIQUEFACTION CONTENTS R=570 E=660, D=400, M9=255, M6=170, OTHER = _________________ 41320 (03/05) INDIANA OXYGEN COMPANY 6099 W. CORPORATE WAY INDIANAPOLIS, IN 46278 317-290-0003

OXYGEN

OXYGEN REFRIGERATED LIQUID

OXYGEN REFRIGERATED LIQUID USP UN 1073 ALWAYS KEEP CONTAINER IN UPRIGHT POSTION CONTENTS _____________________ LOT ______________________ WARNING: OXYGEN COMPRESSED USP UN 1072 PRODUCED BY AIR LIQUEFACTION. WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DIFICIENCY AND RESUCITATION. FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY. UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON ARTERIAL BLOOD MAY BE HARMFUL. DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING, UNLESS USED INCONJUNCTION WITH RESUCITATIVE EQUIPMEN T. EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE VIGOROUSLY ACCELERATES COMBUTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT CAN CAUSE SEVERE FROSTBITE KEEP OIL AND GREASE AWAY. OPEN VALVE SLOWLY. STORE AND USE WITH ADEQUATE VENTILATION. USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE FOR LIQUID WITHDRAWAL, WEAR FACE SHIELD AND GLOVES. DO NOT DROP. USE SUITABLE HAND TRUCK FOR CONTAINER MOVEMENT. AVOID SPILLS. DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F) USE IN ACCORDANCE WITH THE 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 INDIANA OXYGEN COMPANY 6099 W. CORPORATE WAY INDIANAPOLIS, IN 46278 317-290-0003 47136 (10/00)

OXYGEN

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 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 # _________________________ J 700 a1

REVISION 1.0 CERTIFICATE OF ANALYSIS - OXYGEN USP

OXYGEN

Rx Only

DO NOT REMOVE LABEL

OXYGEN

OXYGEN GAS

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:48546-0001
Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Oxygen Oxygen 99 L

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:48546-0001-1 113 in 1 CYLINDER
2 NDC:48546-0001-2 170 in 1 CYLINDER
3 NDC:48546-0001-3 255 in 1 CYLINDER
4 NDC:48546-0001-4 425 in 1 CYLINDER
5 NDC:48546-0001-5 566 in 1 CYLINDER
6 NDC:48546-0001-6 679 in 1 CYLINDER
7 NDC:48546-0001-7 1132 in 1 CYLINDER
8 NDC:48546-0001-8 3114 in 1 CYLINDER
9 NDC:48546-0001-9 4247 in 1 CYLINDER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1960-01-01


OXYGEN

OXYGEN GAS

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:48546-0002
Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Oxygen Oxygen 99.5 L

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:48546-0002-1 6228 in 1 DEWAR
2 NDC:48546-0002-2 9540 in 1 DEWAR
3 NDC:48546-0002-3 164793 in 1 DEWAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1961-01-01


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