Label: OXYGEN- oxygen gas

  • NDC Code(s): 67596-001-01, 67596-001-02, 67596-001-03, 67596-001-04, view more
    67596-001-05
  • Packager: Compressed Gas Solutions Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 19, 2017

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL


    OXYGEN, COMPRESSED USP
    UN1072
    PRODUCED BY AIR LIQUEFACTION
    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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINES GAS UNDER PRESSURE; MAY EXPLODE IF HEATHER. 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 pipping. 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 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use. CAS 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.
    COMPRESSED GAS SOLUTIONS, INC.
    2450 SHADER RD
    ORLANDO, FL 32804
    407-293-3733oxygen

    Close
  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67596-001
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 995 mL  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67596-001-01 416 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001
    2 NDC:67596-001-02 685 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001
    3 NDC:67596-001-03 3554 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001
    4 NDC:67596-001-04 7108 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001
    5 NDC:67596-001-05 9544 L in 1 CYLINDER; Type 0: Not a Combination Product 11/01/2001
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA205827 11/01/2001
    Labeler - Compressed Gas Solutions Inc (122401982)
    Establishment
    Name Address ID/FEI Business Operations
    Compressed Gas Solutions Inc 122401982 manufacture(67596-001)
    Close