OXYGEN

Manufacturer
Indiana Oxygen Company Inc
Effective date
2024-10-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 21:15:35

Label at a glance#

ProductOXYGEN
Active ingredientOXYGEN
Label structure3 sections

Label contents#

Full prescribing information#

OXYGEN COMPRESSED LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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. _____

O2 HPSL1O2 HPSL1

O2 HPSL1O2 HPSL1

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. _____

O2 HPSL2O2 HPSL2

O2 HPSL2O2 HPSL2

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

O2 Body 3O2 Body 3

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 ____________

O2 Body 4O2 Body 4

O2 Body 4O2 Body 4

OXYGEN REFRIGERATED LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

O2 REF LIQO2 REF LIQ

OXYGEN CERTIFICATE OF ANALYSIS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 _____________

COACOA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312172oxygen 99 % Gas for InhalationPSN13
312173oxygen 99.5 % Gas for InhalationPSN13
312174oxygen 99.6 % Gas for InhalationPSN13
312172oxygen 99 % Gas for InhalationSCD13
312173oxygen 99.5 % Gas for InhalationSCD13
312174oxygen 99.6 % Gas for InhalationSCD13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48546-0001-1OXYGEN113 L in 1 CYLINDERGAS11313
48546-0001-2OXYGEN170 L in 1 CYLINDERGAS17013
48546-0001-3OXYGEN255 L in 1 CYLINDERGAS25513
48546-0001-4OXYGEN425 L in 1 CYLINDERGAS42513
48546-0001-5OXYGEN566 L in 1 CYLINDERGAS56613
48546-0001-6OXYGEN679 L in 1 CYLINDERGAS67913
48546-0001-7OXYGEN1132 L in 1 CYLINDERGAS113213
48546-0001-8OXYGEN3114 L in 1 CYLINDERGAS311413
48546-0001-9OXYGEN4247 L in 1 CYLINDERGAS424713
48546-0002-1OXYGEN6228 L in 1 DEWARGAS622813
48546-0002-2OXYGEN9540 L in 1 DEWARGAS954013
48546-0002-3OXYGEN164793 L in 1 DEWARGAS16479313
48546-0002-4OXYGEN164734 L in 1 DEWARGAS16473413
48546-0002-5OXYGEN145632 L in 1 DEWARGAS14563213
48546-0002-6OXYGEN127350 L in 1 DEWARGAS12735013
48546-0002-7OXYGEN164734 L in 1 DEWARGAS16473413
48546-0002-8OXYGEN420 L in 1 CYLINDERGAS42013
48546-0002-9OXYGEN690 L in 1 CYLINDERGAS69013
48546-0004-1OXYGEN570 L in 1 CYLINDERGAS57013
48546-0004-2OXYGEN3470 L in 1 CYLINDERGAS347013
48546-0004-3OXYGEN6900 L in 1 CYLINDERGAS690013
48546-0004-4OXYGEN7760 L in 1 CYLINDERGAS776013
48546-0004-5OXYGEN9340 L in 1 CYLINDERGAS934013
48546-0004-6OXYGEN164.5 L in 1 CYLINDERGAS164.513
48546-0004-7OXYGEN139 L in 1 CYLINDERGAS13913
48546-0004-8OXYGEN248.4 L in 1 CYLINDERGAS248.413
48546-0004-9OXYGEN623 L in 1 CYLINDERGAS62313
48546-0006-1OXYGEN4248 L in 1 CYLINDERGAS424813
48546-0006-2OXYGEN1133 L in 1 CYLINDERGAS113313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48546-0001OXYGEN GAS [INDIANA OXYGEN COMPANY INC]13Current NDC, Legacy NDC, 9 package rows20241025_a116dc52-9522-4cc3-b745-0b0cc3e0d7dd.zip
48546-0002OXYGEN GAS [INDIANA OXYGEN COMPANY INC]13Current NDC, Legacy NDC, 9 package rows20241025_a116dc52-9522-4cc3-b745-0b0cc3e0d7dd.zip
48546-0004OXYGEN GAS [INDIANA OXYGEN COMPANY INC]13Current NDC, Legacy NDC, 9 package rows20241025_a116dc52-9522-4cc3-b745-0b0cc3e0d7dd.zip
48546-0006OXYGEN GAS [INDIANA OXYGEN COMPANY INC]13Current NDC, Legacy NDC, 2 package rows20241025_a116dc52-9522-4cc3-b745-0b0cc3e0d7dd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OXYGENACTIVE INGREDIENTS88TT140651
OXYGENACTIVE MOIETYS88TT140651

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYGENS88TT14065ACTIB
OXYGENS88TT14065ACTIB
OXYGENS88TT14065ACTIB
OXYGENS88TT14065ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYGENOXYGENIndiana Oxygen Company Inca116dc52-9522-4cc3-b745-0b0cc3e0d7dd2024-10-23Exact identifier
ndc (package): 48546-0002-2
ndc (package): 48546-0004-3
ndc (package): 48546-0001-9
ndc (package): 48546-0006-2
ndc (package): 48546-0001-5
ndc (package): 48546-0002-3
ndc (package): 48546-0002-8
ndc (package): 48546-0004-4
ndc (package): 48546-0002-1
ndc (package): 48546-0002-5
ndc (package): 48546-0002-7
ndc (package): 48546-0001-2
ndc (package): 48546-0001-3
ndc (package): 48546-0004-5
ndc (package): 48546-0001-4
ndc (package): 48546-0004-1
ndc (package): 48546-0004-2
ndc (package): 48546-0001-1
ndc (package): 48546-0001-7
ndc (package): 48546-0004-6
ndc (package): 48546-0001-6
ndc (package): 48546-0002-4
ndc (package): 48546-0004-9
ndc (package): 48546-0001-8
ndc (package): 48546-0002-9
ndc (package): 48546-0006-1
ndc (package): 48546-0004-7
ndc (package): 48546-0002-6
ndc (package): 48546-0004-8
ndc (product): 48546-0002
ndc (product): 48546-0001
ndc (product): 48546-0006
ndc (product): 48546-0004
ndc11 (package): 48546000105
ndc11 (package): 48546000208
ndc11 (package): 48546000403
ndc11 (package): 48546000602
ndc11 (package): 48546000205
ndc11 (package): 48546000102
ndc11 (package): 48546000402
ndc11 (package): 48546000104
ndc11 (package): 48546000108
ndc11 (package): 48546000201
ndc11 (package): 48546000406
ndc11 (package): 48546000101
ndc11 (package): 48546000109
ndc11 (package): 48546000409
ndc11 (package): 48546000206
ndc11 (package): 48546000405
ndc11 (package): 48546000209
ndc11 (package): 48546000202
ndc11 (package): 48546000203
ndc11 (package): 48546000408
ndc11 (package): 48546000106
ndc11 (package): 48546000601
ndc11 (package): 48546000204
ndc11 (package): 48546000407
ndc11 (package): 48546000404
ndc11 (package): 48546000207
ndc11 (package): 48546000103
ndc11 (package): 48546000401
ndc11 (package): 48546000107
spl id: 3900254d-9785-4335-b041-9841d2aca5d2
spl set id: a116dc52-9522-4cc3-b745-0b0cc3e0d7dd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.