Label: OXYGEN gas

  • NDC Code(s): 46123-001-01, 46123-001-02, 46123-001-03, 46123-001-04, view more
    46123-001-05, 46123-001-06, 46123-001-07, 46123-001-08, 46123-001-09, 46123-001-10, 46123-001-11, 46123-001-12, 46123-001-13, 46123-001-14, 46123-001-15
  • Packager: Roberts Oxygen Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 18, 2024

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  • PRINCIPAL DISPLAY PANEL

    OXYGEN,
    COMPRESSED
    USP
    UN1072
    OXYGEN 2
    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. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fitting free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventative device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use. CAS 7782-44-7. DO NOT REMOVE THIS PRODUCT LABEL.
    Roberts Oxygen Company, Inc.
    PO Box 5507 Rockville, MD 20855
    301-948-8100

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  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46123-001-01170 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    2NDC:46123-001-02181 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    3NDC:46123-001-03246 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    4NDC:46123-001-04425 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    5NDC:46123-001-05587 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    6NDC:46123-001-06651 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    7NDC:46123-001-07705 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    8NDC:46123-001-081048 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    9NDC:46123-001-093993 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    10NDC:46123-001-107986 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    11NDC:46123-001-119346 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    12NDC:46123-001-124163 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    13NDC:46123-001-13212 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    14NDC:46123-001-1434 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    15NDC:46123-001-15112147 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584901/01/1967
    Labeler - Roberts Oxygen Company, Inc. (042646877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.020325953manufacture(46123-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.037669104manufacture(46123-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.094888112manufacture(46123-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.116950907manufacture(46123-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.121820476manufacture(46123-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.783854045manufacture(46123-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.788511095manufacture(46123-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.791818008manufacture(46123-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.926687468manufacture(46123-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.959266628manufacture(46123-001)
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