Label: OXYGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 27, 2019

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  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP
    UN1072
    PRODUCED BY AIR LIQUEFACTION
    WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and applications. For all other medical application, 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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only by establishment registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. 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 fittings 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 preventive 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.
    Contents (Cu Ft): T-337 H-251 M-125 E-24 D-14
    C-9 B-6 OTHER:
    PURITY CYLINDER GASES, INC.
    2580 28TH ST SW, WYOMING, MI 49519
    616-532-2375 oxygen

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10927-103
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10927-103-09113 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    2NDC:10927-103-10142 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    3NDC:10927-103-11255 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    4NDC:10927-103-12396 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    5NDC:10927-103-13651 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    6NDC:10927-103-141388 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    7NDC:10927-103-151699 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    8NDC:10927-103-163597 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    9NDC:10927-103-177420 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    10NDC:10927-103-189657 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    11NDC:10927-103-191132.68 L in 1 CYLINDER; Type 0: Not a Combination Product10/20/1938
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576710/20/1938
    Labeler - PURITY CYLINDER GASES INC (065878860)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURITY CYLINDER GASES INC006055710manufacture(10927-103)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURITY CYLINDER GASES INC016676728manufacture(10927-103)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURITY CYLINDER GASES INC120042374manufacture(10927-103)