OXYGEN by Indiana Oxygen Company, Inc. OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Indiana Oxygen Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 _____________

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 48546-0001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48546-0001-1	113 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960
2	NDC: 48546-0001-2	170 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960
3	NDC: 48546-0001-3	255 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960
4	NDC: 48546-0001-4	425 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960
5	NDC: 48546-0001-5	566 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960
6	NDC: 48546-0001-6	679 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960
7	NDC: 48546-0001-7	1132 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960
8	NDC: 48546-0001-8	3114 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960
9	NDC: 48546-0001-9	4247 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205767	01/01/1960

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 48546-0002
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99.5 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48546-0002-1	6228 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1961
2	NDC: 48546-0002-2	9540 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1961
3	NDC: 48546-0002-3	164793 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1961

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205767	01/01/1961

Labeler - Indiana Oxygen Company, Inc. (006036776)

Registrant - Indiana Oxygen Company, Inc. (006036776)

Establishment
Name	Address	ID/FEI	Business Operations
Indiana Oxygen Company, Inc.		006036776	manufacture(48546-0001, 48546-0002)