Label: OXYGEN gas

  • NDC Code(s): 58089-001-01, 58089-001-02, 58089-001-03
  • Packager: Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

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Drug Label Information

Updated November 14, 2019

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  • Principal for Oxygen Product

    RespresentativeLoxLabel

    OXYGEN,

    REFRIGERATED

    LIQUID USP

    UN 1073

    CONTENTS ________________LITERS

    CAS NO: 7782-44-7

    DANGER:

    REFRIGERATED LIQUEFIED OXIDIZING GAS. ALWAYS

    KEEP CONTAINER IN UPRIGHT POSITION. DO NOT

    CHANGE OR FORCE FIT CONNECTIONS. 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 get in eyes, on skin, or on clothing. Keep reduction valves free

    from grease and oil. In case of fire, stop leak if safe to do so. Avoid

    spills. Do not walk or roll equipment over spills. Store and use 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. Protect from sunlight when ambient

    temperature exceeds 52 F. Container temperature should

    not exceed 52 F. Close valve after each use and when

    empty. Use a back flow preventative 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 combustible materials. Do not drop. Use suitable hand truck for

    container movement.

    FIRST AID:

    IN CASE OF FROSTBITE: Thaw frosted parts with lukewarm water.

    Do not rub affected area. Get immediate medical advice/attention.

    DO NOT REMOVE THIS PRODUCT LABEL.

    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. Use only with pressure

    reducing equipment and apparatus designed for oxygen. Do not

    attempt to use on patients who have stopped breathing unless used in

    conjunction with resuscitative equipment. Produced by Air Liquefaction.

    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

    RepresentativeLotSticker

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58089-001
    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:58089-001-0245 L in 1 DEWAR; Type 0: Not a Combination Product12/02/2009
    2NDC:58089-001-0360 L in 1 DEWAR; Type 0: Not a Combination Product12/02/2009
    3NDC:58089-001-0141 L in 1 DEWAR; Type 0: Not a Combination Product12/02/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas12/02/2009
    Labeler - Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment (161365424)
    Establishment
    NameAddressID/FEIBusiness Operations
    Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment081030274manufacture(58089-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Manuel Enterprises, Inc. dba Nepenthe Home Medical Equipment161365424manufacture(58089-001)