Label: OXYGEN- oxygen gas

  • NDC Code(s): 59301-001-01, 59301-001-02, 59301-001-03, 59301-001-04, view more
    59301-001-05, 59301-001-06, 59301-001-07, 59301-001-08, 59301-001-09, 59301-001-10, 59301-001-11
  • Packager: Oxygen Support Systems Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 28, 2018

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  • Principal for Oxygen Product

    RepresentativeHPLabel

    OXYGEN

    COMPRESSED

    USP

    UN 1072

    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 piping. 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 when ambient temperature exceeds 52 °c (125 °F). Read and follow the Safety Data Sheet (SDS) before use.

    CAS NO: 7782-44-7

    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 used in conjunction with resuscitative equipment. Produced by Air Liquefaction.

    RepresentativeLoxLabel

    OXYGEN,

    REFRIGERATED

    LIQUID USP

    UN 1073

    CONTENTS ________________LITERS

    CAS NO: 7782-44-7

    DANGER:

    REFRIGERATED LIQUEFIED OXIDIZING GAS. ALWAYS

    KEEP CONTAINER IN UPRIGHT POSITION. DO NOT

    CHANGE OR FORCE FIT CONNECTIONS. MAY CAUSE OR INTENSIFY

    FIRE; OXIDIZER, CONTAINS REFRIGERATED GAS: MAY CAUSE

    CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH

    LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

    Do not get in eyes, on skin, or on clothing. Keep reduction valves free

    from grease and oil. In case of fire, stop leak if safe to do so. Avoid

    spills. Do not walk or roll equipment over spills. Store and use in a well

    ventilated place. Use only with equipment of compatible materials

    of construction and rated for cylinder pressure. Wear cold insulating

    gloves/face shield/eye protection. Protect from sunlight when ambient

    temperature exceeds 52 F. Container temperature should

    not exceed 52 F. Close valve after each use and when

    empty. Use a back flow preventative device in the piping. Do not

    handle until all safety precautions have been read and understood.

    Use only with equipment cleaned for oxygen service. Keep/store away

    from combustible materials. Do not drop. Use suitable hand truck for

    container movement.

    FIRST AID:

    IN CASE OF FROSTBITE: Thaw frosted parts with lukewarm water.

    Do not rub affected area. Get immediate medical advice/attention.

    DO NOT REMOVE THIS PRODUCT LABEL.

    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. Use only with pressure

    reducing equipment and apparatus designed for oxygen. Do not

    attempt to use on patients who have stopped breathing unless used in

    conjunction with resuscitative equipment. Produced by Air Liquefaction.

    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

    Close
  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59301-001
    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:59301-001-01 155 L in 1 CYLINDER; Type 0: Not a Combination Product 08/31/2011
    2 NDC:59301-001-02 240 L in 1 CYLINDER; Type 0: Not a Combination Product 08/31/2011
    3 NDC:59301-001-03 460 L in 1 CYLINDER; Type 0: Not a Combination Product 08/31/2011
    4 NDC:59301-001-04 680 L in 1 CYLINDER; Type 0: Not a Combination Product 08/31/2011
    5 NDC:59301-001-05 200 L in 1 CYLINDER; Type 0: Not a Combination Product 08/31/2011
    6 NDC:59301-001-06 3600 L in 1 CYLINDER; Type 0: Not a Combination Product 08/31/2011
    7 NDC:59301-001-07 1738 L in 1 CYLINDER; Type 0: Not a Combination Product 08/31/2011
    8 NDC:59301-001-08 7080 L in 1 CYLINDER; Type 0: Not a Combination Product 08/31/2011
    9 NDC:59301-001-09 21 L in 1 DEWAR; Type 0: Not a Combination Product 08/31/2011
    10 NDC:59301-001-10 31 L in 1 DEWAR; Type 0: Not a Combination Product 08/31/2011
    11 NDC:59301-001-11 41 L in 1 DEWAR; Type 0: Not a Combination Product 08/31/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved medical gas 08/31/2011
    Labeler - Oxygen Support Systems Inc (021974241)
    Establishment
    Name Address ID/FEI Business Operations
    Oxygen Support Systems Inc 021974241 manufacture(59301-001)
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