Label: OXYGEN- oxygen gas

  • NDC Code(s): 12213-720-10, 12213-720-12, 12213-720-13, 12213-720-15, view more
    12213-720-16, 12213-720-17, 12213-720-37, 12213-720-43, 12213-720-44, 12213-720-45, 12213-720-46, 12213-720-47, 12213-720-48, 12213-720-50, 12213-720-53, 12213-720-58, 12213-720-59, 12213-720-62, 12213-720-63, 12213-720-67
  • Packager: NexAir, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 1, 2016

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

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP UN1072
    OXYGEN 2 OXYGEN PRODUCED BY AIR LIQUIFACTION Rx only.
    DANGER: MAY CAUSE OR INTENCIFY FIRE; OXYDIZER. 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. WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical application, 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. 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. Keep out of reach of children. DO NOT REMOVE THIS PRODUCT LABEL CAS: 7782-44-7
    nexAir
    Distributed by nexAir, LLC . www.nexAir.com
    1385 Corporate Ave. . Memphis, TN 38132 . 888-639-2474
    LOT #: PART #: CF. LITERS:

    oxygen one

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  • PRINCIPAL DISPLAY PANEL

    REFRIGERATED LIQUID OXYGEN, REFRIGERATED LIQUID USP UN1073 CAS: 7782-44-7
    NIET CONTENTS Part # C.F. Liters (Gaseous)
    LQ OX-USP-GP55 5436 153,931
    LQ O-USP-L1 4844 137,169
    CO OX-DEWAR-20 912 25,810
    Rx ONLY
    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 filled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.
    Produced by Air Liquiefaction.
    DANGER: MAY CAUSE OR INTENSIFY FIRE; OXYDIZER. 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 sfe to do so. Use a back flow preventive device inthe 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 foll equipment over spills. Close valve after each use and when empty. Alway 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.
    Distributed by nexAir nexAir, LLC . www.nexAir.com
    1385 Corporate Ave. . Memphis, TN 38132 . 888-639-2474

    oxygen two

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  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12213-720
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 991 mL  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:12213-720-59 170 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    2 NDC:12213-720-62 255 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    3 NDC:12213-720-13 408 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    4 NDC:12213-720-53 566 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    5 NDC:12213-720-58 663 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    6 NDC:12213-720-43 30 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    7 NDC:12213-720-44 31 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    8 NDC:12213-720-15 1133 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    9 NDC:12213-720-45 41 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    10 NDC:12213-720-46 43 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    11 NDC:12213-720-63 1699 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    12 NDC:12213-720-50 2350 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    13 NDC:12213-720-37 3511 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    14 NDC:12213-720-17 4361 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    15 NDC:12213-720-12 7051 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    16 NDC:12213-720-16 2979 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    17 NDC:12213-720-10 9543 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    18 NDC:12213-720-67 127567 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    19 NDC:12213-720-47 137167 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    20 NDC:12213-720-48 153930 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/1996
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA205849 06/01/1996
    Labeler - NexAir, LLC (927024422)
    Establishment
    Name Address ID/FEI Business Operations
    NexAir, LLC 792042108 manufacture(12213-720)
    Establishment
    Name Address ID/FEI Business Operations
    NexAir, LLC 927024422 manufacture(12213-720)
    Establishment
    Name Address ID/FEI Business Operations
    NexAir, LLC 844628334 manufacture(12213-720)
    Establishment
    Name Address ID/FEI Business Operations
    NexAir, LLC 603601050 manufacture(12213-720)
    Establishment
    Name Address ID/FEI Business Operations
    NexAir, LLC 969017086 manufacture(12213-720)
    Establishment
    Name Address ID/FEI Business Operations
    NexAir, LLC 192167567 manufacture(12213-720)
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