Label: OXYGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

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Drug Label Information

Updated May 12, 2014

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  • Principal for Oxygen Product

    OXYGEN, COMPRESSED USP
    UN 1072
    C.A.S No. 7782-44-7
    WARNING: HIGH PRESSURE, OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION.
    Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation.
    Use only with equipment cleaned for oxygen service and rated for cylinder pressure.
    Use a back flow preventative device in the piping.
    Close valve after each use and when empty. Cylinder temperatures should not exceed 52°C (125°F).
    Use in accordance with Material Safety Data Sheet (MSDS).
    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. 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

    OXYGEN,
    REFRIGERATED LIQUID
    USP
    UN 1073
    CONTENTS: LITERS

    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

    WARNING:
    DO NOT CHANGE OR FORCE FIT CONNECTIONS
    EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE
    VIGOROUSLY ACCELERATES COMBUSTION
    NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT
    COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE
    ON IGNITION OR IMPACT.
    CAN CAUSE SEVERE FROSTBITE.
    Keep oil, grease, and combustibles away.
    Use only with equipment cleaned for oxygen service.
    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 suitable hand truck for container movement.
    Container temperatures should not exceed 52 degrees C ( 125 degrees F).
    Close valve after each use and when empty.
    Use a back flow preventive device in the piping.
    Use in accordance with the Material Safety Data Sheet (MSDS).

    FIRST AID:
    IN CASE OF FROSTBITE, obtain medical treatment immediately.

    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. 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 LiquefactionHP Label

    Lot Sticker

    LoxLabel

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63699-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63699-001-01160 L in 1 CYLINDER
    2NDC:63699-001-02410 L in 1 CYLINDER
    3NDC:63699-001-03670 L in 1 CYLINDER
    4NDC:63699-001-04113 L in 1 CYLINDER
    5NDC:63699-001-053470 L in 1 CYLINDER
    6NDC:63699-001-0633756 L in 1 DEWAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas08/31/2012
    Labeler - Ablecare Medical, Inc. (787597202)
    Registrant - Ablecare Medical, Inc. (787597202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ablecare Medical, Inc.787597202manufacture(63699-001)