Label: OXYGEN gas

  • NDC Code(s): 84233-001-01, 84233-001-02, 84233-001-03, 84233-001-04, view more
    84233-001-05
  • Packager: Rocky Mountain Medical Equipment LLC
  • 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 March 11, 2024

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  • Principal for Oxygen Product

    HP Label

    OXYGEN,
    REFRIGERATED
    LIQUID USP
    UN 1073

    CONTENTS:___________ LITERS

    CAS NO: 7782-44-7
    DANGER:
    MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS
    REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR
    INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY
    EXPLODE ON IGNITION OR IMPACT.
    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. Wear cold insulating
    gloves, face shield, and eye protection. 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.
    DO NOT change or force fit connections. Avoid spills. Do
    not walk on or roll equipment over spills. Close valve after each use
    and when empty. Always keep container in upright position. 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 advice/attention.
    DO NOT REMOVE THIS PRODUCT LABEL.
    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. Produced by Air Liquefaction.

    KEEP OUT OF REACH OF CHILDREN

    RepresentativeLotSticker

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:84233-001
    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:84233-001-0231 L in 1 DEWAR; Type 0: Not a Combination Product03/11/2024
    2NDC:84233-001-0341 L in 1 DEWAR; Type 0: Not a Combination Product03/11/2024
    3NDC:84233-001-0121 L in 1 DEWAR; Type 0: Not a Combination Product03/11/2024
    4NDC:84233-001-0445.7 L in 1 DEWAR; Type 0: Not a Combination Product03/11/2024
    5NDC:84233-001-0560.2 L in 1 DEWAR; Type 0: Not a Combination Product03/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas03/11/2024
    Labeler - Rocky Mountain Medical Equipment LLC (119225581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rocky Mountain Medical Equipment LLC119225581manufacture(84233-001)