Label: OXYGEN gas

  • NDC Code(s): 54528-001-01, 54528-001-02, 54528-001-03, 54528-001-04, view more
    54528-001-05, 54528-001-06, 54528-001-07, 54528-001-08, 54528-001-09, 54528-001-10
  • Packager: Commonwealth Home Health Care, Inc.
  • 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 January 19, 2024

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

  • PRINCIPAL DISPLAY PANEL

    OXYGEN,
    COMPRESSED
    USP
    UN1072
    PRODUCED BY AIR LIQUIFACTION
    OXYGEN 2
    18033 (12/14)
    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 durationn, 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. 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 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 cpmpatible 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
    COMMONWEALTH HOME HEALTH CARE
    479 PINEY FOREST ROAD · DANVILLE, VA 24540
    434-797-2332

    gas2.jpg

  • PRINCIPAL DISPLAY PANEL

    Oxygen,
    Refrigerated
    Liquid USP
    UN 1073
    Oxygen 2

    DANGER:
    CONTAINS REFRIGERATED GAS: MAY CAUSE CRYOGENIC BURNS OR INJURY. MAY CAUSE OR INTENSIFY FIRE: OXIDIZER.
    COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

    Do not get into eyes, on skin, or on clothing. Keep valves and fittings free from grease and oil. Do not smoke. In case of fire: Stop leak if safe to do so. Avoid spills. Do not walk or roll equipment over spills. Use and store only outdoors or in a well ventilated place. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Wear cold insulating gloves/face shield/eye protection. Do not drop. Use suitable hand truck for container movement. Close valve after each use and when empty. Use a back flow preventive device in the piping. Do not handle until all safety precautions have been read and understood. Use only with equipment cleaned for oxygen service. Keep/store away from clothing and other combustible materials. Always keep container in upright position. DO NOT change or force fit connections. Read and follow the Safety Data Sheet (SDS) before use.

    FIRST AID:
    IF ON SKIN: Thaw frosted parts with lukewarm water.
    Do not rub affected area. Get immediate medical attention.

    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.
    Produced by Air Liquefaction.

    DO NOT REMOVE THIS PRODUCT LABEL
    CAS: 7782-44-7

    Commonwealth Home Health Care, Inc.
    479 Piney Forest Road
    Danville, VA 24540
    434-797-2332

    Liquid Oxygen Label

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54528-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN995 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54528-001-01165 L in 1 CYLINDER; Type 0: Not a Combination Product10/31/2014
    2NDC:54528-001-02395 L in 1 CYLINDER; Type 0: Not a Combination Product10/31/2014
    3NDC:54528-001-03655 L in 1 CYLINDER; Type 0: Not a Combination Product10/31/2014
    4NDC:54528-001-043540 L in 1 CYLINDER; Type 0: Not a Combination Product10/31/2014
    5NDC:54528-001-057960 L in 1 CYLINDER; Type 0: Not a Combination Product10/31/2014
    6NDC:54528-001-0630 L in 1 DEWAR; Type 0: Not a Combination Product10/31/2014
    7NDC:54528-001-0740 L in 1 DEWAR; Type 0: Not a Combination Product10/31/2014
    8NDC:54528-001-081699 L in 1 CYLINDER; Type 0: Not a Combination Product10/31/2014
    9NDC:54528-001-0936 L in 1 DEWAR; Type 0: Not a Combination Product10/31/2014
    10NDC:54528-001-1046 L in 1 DEWAR; Type 0: Not a Combination Product10/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas10/31/2014
    Labeler - Commonwealth Home Health Care, Inc. (119079945)
    Registrant - Commonwealth Home Health Care, Inc. (119079945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Commonwealth Home Health Care, Inc.119154173manufacture(54528-001)