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 February 19, 2010

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  • PRINCIPAL DISPLAY PANEL

    OXYGEN,
    COMPRESSED

    UN1072

    OXYGEN*, USP

    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.

    WARNING: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. 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. Close valve after each use and when empty. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52°C (125°F). Use in accordance with the Material Safety Data Sheet (MSDS).

    *PRODUCED BY AIR LIQUEFACTION                          RETURN WITH 25 PSIG.

    TO BE REFILLED BY AN INWELD AUTHORIZED FACILITY ONLY.   RETURN WITH 25 PSIG.

    Pressure: ___________  PSIG at 70°F
    Size: _______________
    Contents: ___________  Liters
    DO NOT REMOVE THIS PRODUCT LABEL.

    Compressed Oxygen Label

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49778-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen992 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49778-001-01140 mL in 1 CYLINDER
    2NDC:49778-001-02387 mL in 1 CYLINDER
    3NDC:49778-001-03643 mL in 1 CYLINDER
    4NDC:49778-001-043511 mL in 1 CYLINDER
    5NDC:49778-001-057051 mL in 1 CYLINDER
    6NDC:49778-001-068690 mL in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas05/01/2009
    Labeler - American Welding & Gas (035216530)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Welding & Gas832328061manufacture