Label: OXYGEN gas

  • NDC Code(s): 61520-001-01, 61520-001-02, 61520-001-03, 61520-001-04, view more
    61520-001-05, 61520-001-06, 61520-001-07, 61520-001-09, 61520-001-10, 61520-001-11, 61520-001-12, 61520-001-13, 61520-001-14
  • Packager: Premier Medical Distribution
  • 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 December 16, 2024

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  • Principal for Oxygen Product

    RepresentativeHPLabel

    OXYGEN

    COMPRESSED

    USP

    UN 1072

    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 a well-ventilated place. 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. 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 NO: 7782-44-7

    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

    RepresentativeLoxLabel

    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.

    RepresentativeLotSticker

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61520-001
    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:61520-001-01415 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    2NDC:61520-001-02248 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2009
    3NDC:61520-001-03165 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    4NDC:61520-001-04682 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    5NDC:61520-001-0560 L in 1 DEWAR; Type 0: Not a Combination Product05/22/2007
    6NDC:61520-001-0647 L in 1 DEWAR; Type 0: Not a Combination Product05/22/2007
    7NDC:61520-001-076910 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    8NDC:61520-001-09113 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    9NDC:61520-001-10164 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    10NDC:61520-001-11198 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    11NDC:61520-001-12640 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    12NDC:61520-001-131738 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    13NDC:61520-001-143455 L in 1 CYLINDER; Type 0: Not a Combination Product05/22/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas05/22/2007
    Labeler - Premier Medical Distribution (015155753)
    Registrant - Premier Medical Distribution (015155753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Premier Medical Distribution015155753manufacture(61520-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Premier Medical Distribution080319559manufacture(61520-001)