Label: OXYGEN gas

  • NDC Code(s): 66365-001-01, 66365-001-02, 66365-001-03, 66365-001-04, view more
    66365-001-05, 66365-001-06, 66365-001-07, 66365-001-08, 66365-001-09, 66365-001-10, 66365-001-11, 66365-001-12
  • Packager: Medical Comfort Systems Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 10, 2023

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  • PRINCIPAL DISPLAY PANEL

    OXYGEN, REFRIGERATED LIQUID USP

    UN1073

    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.

    Medical Comfort Systems Inc

    112 White Oak Lane Suite A

    Lexington, SC 29073

    1-800-765-4697 oxygen

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66365-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN998 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66365-001-0170 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2001
    2NDC:66365-001-02248 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2001
    3NDC:66365-001-03415 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2001
    4NDC:66365-001-04682 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2001
    5NDC:66365-001-051724 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2001
    6NDC:66365-001-063452 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/2001
    7NDC:66365-001-0716750 L in 1 DEWAR; Type 0: Not a Combination Product06/01/2001
    8NDC:66365-001-0824950 L in 1 DEWAR; Type 0: Not a Combination Product06/01/2001
    9NDC:66365-001-0929069 L in 1 DEWAR; Type 0: Not a Combination Product06/01/2001
    10NDC:66365-001-1033500 L in 1 DEWAR; Type 0: Not a Combination Product06/01/2001
    11NDC:66365-001-1137619 L in 1 DEWAR; Type 0: Not a Combination Product06/01/2001
    12NDC:66365-001-1238300 L in 1 DEWAR; Type 0: Not a Combination Product06/01/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584906/01/2001
    Labeler - Medical Comfort Systems Inc (037401429)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Comfort Systems Inc037401429manufacture(66365-001)