Label: OXYGEN- oxygen gas

  • NDC Code(s): 48546-0001-1, 48546-0001-2, 48546-0001-3, 48546-0001-4, view more
    48546-0001-5, 48546-0001-6, 48546-0001-7, 48546-0001-8, 48546-0001-9, 48546-0002-1, 48546-0002-2, 48546-0002-3
  • Packager: Indiana Oxygen Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 11, 2017

If you are a consumer or patient please visit this version.

  • 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. _____

    O2 1

    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 2

    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 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 4

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  • 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

    O2 REF LIQ

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  • 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 _____________

    COA

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  • 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)
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