Label: OXYGEN- oxygen gas
OXYGEN- oxygen liquid

  • NDC Code(s): 59400-001-01, 59400-001-02, 59400-001-03, 59400-001-04, view more
    59400-005-01, 59400-005-02, 59400-005-03, 59400-005-04
  • Packager: BayCare Home Care, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

Drug Label Information

Updated 10/14

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

  • Oxygen U.S.P.


    Oxygen Gas Label










    UN1072
    WARNING!
    High Pressure Oxidizing Gas Vigorously Accelerates Combustion

    Produced by Air Liquefaction

    Warning!
    For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.

    Caution: RX ONLY
    For other medical applications, use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours, may be harmful. Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.

    Keep out of reach of children. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with pressure reducing equipment and apparatus designed for oxygen service and rated for cylinder pressure. Open valve slowly before use. Close valve after each use and when empty.

    Federal law requires that this container be refilled with Gaseous Oxygen USP only by establishments registered as a Drug producer in accordance with the Federal Food, Drug and Cosmetic Act.

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  • Refrigerated Liquid Oxygen U.S.P.

    Oxygen Liquid Label











    UN1073
    WARNING!

    High Pressure Oxidizing Liquid and Gas Under Pressure
    Vigorously Accelerates Combustion
    May Explode on Ignition or Impact
    Can Cause Severe Frostbite

    PRODUCED BY AIR LIQUEFACTION   

    Caution:  RX Only
    Warning!

    Keep oil, grease and combustibles away. Store and use with adequate ventilation. Do not get liquid in eyes, on skin, or clothing. For liquid withdrawal, wear face shield and gloves. Do not drop. Use hand truck for container movement. Avoid spills. Do not walk or roll equipment over spills. Close valve after each use and when empty.

    In case of frostbite, obtain medical treatment IMMEDIATELY.

    Keep out of reach of children. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with equipment and apparatus conditioned for oxygen service.

    Use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.

    Federal law requires that this container be refilled with Liquid Oxygen USP only by establishments registered as a Drug Producer in accordance with the Federal Food, Drug and Cosmetic Act.

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  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59400-001
    Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Oxygen (Oxygen) Oxygen 210 mL  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59400-001-01 670 L in 1 CYLINDER
    2 NDC:59400-001-02 425 L in 1 CYLINDER
    3 NDC:59400-001-03 140 L in 1 CYLINDER
    4 NDC:59400-001-04 7760 L in 1 CYLINDER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved medical gas 10/29/2013
    OXYGEN 
    oxygen liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59400-005
    Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Oxygen (Oxygen) Oxygen 210 mg  in 1 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59400-005-01 34168 kg in 1 DEWAR
    2 NDC:59400-005-02 37585 kg in 1 DEWAR
    3 NDC:59400-005-03 25626 kg in 1 DEWAR
    4 NDC:59400-005-04 17084 kg in 1 DEWAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved medical gas 11/05/2013
    Labeler - BayCare Home Care, Inc. (794046607)
    Registrant - BayCare Home Care, Inc. (794046607)
    Establishment
    Name Address ID/FEI Business Operations
    BayCare Home Care, Inc. 794046607 manufacture(59400-001, 59400-005)
    Establishment
    Name Address ID/FEI Business Operations
    BayCare Home Care, Inc. 832097617 manufacture(59400-001, 59400-005)
    Establishment
    Name Address ID/FEI Business Operations
    BayCare Home Care, Inc. 832097591 manufacture(59400-001, 59400-005)
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