Label: OXYGEN gas

  • NDC Code(s): 64097-0001-1, 64097-0001-2, 64097-0001-3, 64097-0001-4
  • Packager: Alternacare Home Health Services
  • 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 October 21, 2023

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

  • WARNINGS AND PRECAUTIONS

    WARNING:
    HIGH PRESSURE GAS CYLINDER

    Improper filling or abuse of this cylinder, or failure to heed this warning may cause serious injury or loss of life. DO NOT ALTER OR MODIFY CYLINDER OR RELATED COMPONENTS. DO NOT OVER PRESSURIZE. Keep out of the reach of children. Cylinders that have been refinished and/or exposed to elevated temperatures must be hydrostatically tested before filling. Do not use caustic paint strippers. Aluminum cylinders subject to action of fire or heated to temperatures in excess of 350 F must be withdrawn from service and condemned. Valves and safety relief devices must be removed and replaced by trained personnel. Do not alter or change safety discs. Replace pressure relief devices only with complete assemblies supplied by the valve manufacturer. DO NOT FILL WITH OXIDIZING GASES WITHOUT PROPER CLEANING. Cylinders, valves and assemblies must be specially cleaned for oxygen. Verify cylinder content and pressure monthly, or more frequently if required. Store and use with adequate ventilation.

  • WARNINGS

    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.

    WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATED COMBUSTION

    Use only with pressure reducing equipment and apparatus cleaned and designed for oxygen service and rated for cylinder pressure.

    Open valve slowly. Close valve after each use and when empty. Keep cylinder, cylinder valve, all equipment that connects, free of oil and grease to avoid violent ignition.

    Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance wiith the Federal Food, Drug, and Cosmetic Act.

    Pursuant to recommendations by Compressed Gas Association, do not expose pressurized cylinders to temperatures in excess of 125 F

    DO NOT REMOVE THIS PRODUCT LABEL

    Use a back flow preventative device in the piping.

    Use only in accordance with product instructions and material safety data sheet.

  • PRINCIPAL DISPLAY PANEL

    OXYGEN

    COMPRESSED

    U.S.P. UN 1072

    Produced by Air Liquefaction

    OXYGEN - 2

    Cylinder Contents at 70 F

    Type B - 142 liters at 1900 psig

    Type C - 235 liters at 1900 psig

    Type D - 393 liters at 1900 psig

    Type E - 646 liters at 1900 psig

    Date code 1104 Label 0035-17(1)

    alternacare_ox

    res

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64097-0001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99.5 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64097-0001-1142 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1996
    2NDC:64097-0001-2235 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1996
    3NDC:64097-0001-3393 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1996
    4NDC:64097-0001-4646 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1996
    Labeler - Alternacare Home Health Services (946763364)
    Registrant - Alternacare Home Health Services (946763364)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alternacare Home Health Services946763364manufacture(64097-0001)