Label: OXYGEN- oxygen gas

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

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Drug Label Information

Updated June 6, 2012

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  • PRINCIPAL DISPLAY PANEL

    MANIILAQ HEALTH CENTER
    USP 93% OXYGEN
    H-01
    50789-436-01 OXYGEN H CYLINDER 6900 LITER

    OXYGEN 93%
    U.S.P.

    OXYGEN
    2

    Net Contents:
    Oxygen (O2):  93% ± 3%
    Nitrogen (N2):  4% ±  2%
    Argon (Ar):  3% ± 1.5%
    Carbon Dioxide (CO2):  <300 ppm
    Carbon Monoxide (CO):  <10 ppm

    WARNING:  HIGH PRESSURE
    OXIDIZING GAS.  VIGOROUSLY
    ACCELERATES COMBUSTION.

    Keep oil and grease away.
    No smoking in cylinder area.
    Open and Close valves slowly.
    Secure cylinder in storage and use.
    Close valve after each use and when empty.
    Store and use with adequate ventalation.
    Use a backflow preventative device in the piping.
    Cylinder temperature should not exceed 52° C (125° F).
    Use in accordance with Material Safety Data Sheet (MSDS).
    Use only with equipment cleaned for oxygen service and rated for cylinder pressure.

    WARNING:  Federal Law prohibits filling this cylinder with Oxygen USP.
    This cylinder may only be filled on the CFP oxygen generator system.

    For emergency use only when administered by properly trained
    personnel for oxygen deficiency and resuscitation.  For all other
    medical applications, Rx only.

    Uniterrupted 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.

    Use only with pressure reducing equipment and apparatus designed for oxygen.
    Return with at least 25 PSIG pressure.

    DO NOT REMOVE THIS PRODUCT LABEL

    Oxygen Canister Label
  • INGREDIENTS AND APPEARANCE
    OXYGEN  
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50789-436
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen930 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Nitrogen (UNII: N762921K75)  
    Argon (UNII: 67XQY1V3KH)  
    Carbon Dioxide (UNII: 142M471B3J)  
    Carbon Monoxide (UNII: 7U1EE4V452)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50789-436-016900 L in 1 CYLINDER
    2NDC:50789-436-02660 L in 1 CYLINDER
    3NDC:50789-436-03400 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/2012
    Labeler - Maniilaq Association (081923526)
    Establishment
    NameAddressID/FEIBusiness Operations
    Maniilaq Association081923526MANUFACTURE