Label: OXYGEN gas

  • 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 September 11, 2017

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  • PRINCIPAL DISPLAY PANEL

    Oxygen

    OXYGEN, COMPRESSED USP

    UN 1072

    C.A.S. NO. 7782-44-7

    PRODUCED BY AIR LIQUEFACTION



    WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.



    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 use in conjunction with resuscitative equipment.



    CAUTION:

    Keep oil and grease away.

    Store and use with adequate ventilation

    . Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.



    Cylinder temperature should not exceed 52 oC (125 oF).



    USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

    DO NOT REMOVE THIS PRODUCT LABEL.

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  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63234-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99.4 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63234-001-1010 L in 1 DEWAR; Type 0: Not a Combination Product01/01/201101/22/2016
    2NDC:63234-001-2020 L in 1 DEWAR; Type 0: Not a Combination Product01/01/201101/08/2016
    3NDC:63234-001-3030 L in 1 DEWAR; Type 0: Not a Combination Product01/01/201101/22/2016
    4NDC:63234-001-4545 L in 1 DEWAR; Type 0: Not a Combination Product01/01/201101/05/2016
    5NDC:63234-001-6060 L in 1 DEWAR; Type 0: Not a Combination Product01/01/201101/22/2016
    6NDC:63234-001-01165 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2011
    7NDC:63234-001-02255 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2011
    8NDC:63234-001-03425 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2011
    9NDC:63234-001-04680 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/2011
    Labeler - Olympic Pharmacy and Healthcare Services (027319854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Olympic Pharmacy and Healthcare Services027319854manufacture(63234-001)