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 January 3, 2011

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  • PRINCIPAL DISPLAY PANEL

    Oxygen cylinder label

    OXYGEN, COMPRESSED USP
    UN 1072

    OXYGEN  2

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

    American Home Respiratory Care Inc.

    2672 Ridge Road West
    Greece, NY  14626
    585-271-1140

    WARNING: HIGH PRESSURE, OXIDIZING GAS.  VIGOROUSLY ACCELERATES COMBUSTION.  NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT
    .  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 temperature should not exceed 52oC (125oF).  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.

           Size     Contents                       Size      Contents 
    [   ]  M6        170 Liters           [   ]     E            682  Liters
    [   ]  C          248 Liters            [   ]     H         6910  Liters
    [   ]  D          415 Liters            [   ]  Other     ____  Liters

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68515-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen992 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68515-001-01113 L in 1 CYLINDER
    2NDC:68515-001-02170 L in 1 CYLINDER
    3NDC:68515-001-03425 L in 1 CYLINDER
    4NDC:68515-001-04680 L in 1 CYLINDER
    5NDC:68515-001-0534195 L in 1 DEWAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/03/2011
    Labeler - American Home Respiratory Care, Inc. (119595481)