Label: OXYGEN gas

  • NDC Code(s): 49798-001-01, 49798-001-02, 49798-001-03, 49798-001-04
  • Packager: James Oxygen and Supply Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 18, 2023

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  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED U.S.P. UN 1072 OXYGEN 2
    CAUTION: RX ONLY.
    WARNING: SECURE ALL CYLINDERS WHILE IN STORAGE AND USE.
    WARNING: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION.
    Keep oil and grease away. Open valve slowly. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Close valve after each use and when empty. Use in accordance with Safety Data Sheet or safety precautions recommended by the supplier. For oxygen deficiency in breathing persons or emergency resuscitation when use by personnel instructed in oxygen administration. For other medical applications, use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content or arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Contents: Cu.Ft. Tank Size:
    DO NOT REMOVE THIS LABEL. PRODUCED BY AIR LIQUEFACTION.
    JAMES OXYGEN AND SUPPLY 30 HIGHWAY 321 NW HICKORY, NC 28601 828-322-5438 oxygen one

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49798-001
    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:49798-001-01424 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1956
    2NDC:49798-001-02679 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1956
    3NDC:49798-001-037249 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1956
    4NDC:49798-001-043539 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1956
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576701/01/1956
    Labeler - James Oxygen and Supply Company (024624348)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Oxygen and Supply Company024624348manufacture(49798-001)