Label: OXYGEN gas

  • NDC Code(s): 11043-011-01, 11043-011-02, 11043-011-03, 11043-011-04, view more
    11043-011-05, 11043-011-06, 11043-011-07, 11043-011-08
  • Packager: S. J. Smith Co., Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated July 1, 2020

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  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP

    UN1072

    PRODUCED BY AIR LIQUEFACTION

    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 refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. 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 7782-44-7

    DO NOT REMOVE THIS PRODUCT LABEL.

    S.J. SMITH CO.

    3707 WEST RIVE DR. DAVENPORT, IA 52802

    563-324-5237oxygen one

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP

    UN1072

    PRODUCED BY AIR LIQUEFACTION

    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 refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. 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 7782-44-7

    DO NOT REMOVE THIS PRODUCT LABEL.

    S.J. SMITH CO.

    3707 WEST RIVE DR. DAVENPORT, IA 52802

    563-324-5237oxygen two

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, REFRIGERATED LIQUID USP

    UN1073

    145692 LTRS:

    CONTENTS: CU FT:

    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 refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

    Produced by Air Liquefaction.

    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 IGINITION 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.

    CAS: 7782-44-7

    DO NOT REMOVE THIS PRODUCT LABEL.

    S.J. SMITH CO.

    3707 WEST RIVE DR. DAVENPORT, IA 52802

    563-324-5237oxygen three

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, REFRIGERATED LIQUID USP

    UN1073

    145692 LTRS:

    CONTENTS: CU FT:

    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 refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

    Produced by Air Liquefaction.

    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 IGINITION 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.

    CAS: 7782-44-7

    DO NOT REMOVE THIS PRODUCT LABEL.

    S.J. SMITH CO.

    3707 WEST RIVE DR. DAVENPORT, IA 52802

    563-324-5237oxygen four

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11043-011
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN992 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11043-011-01154326 L in 1 DEWAR
    2NDC:11043-011-027107 L in 1 CYLINDER
    3NDC:11043-011-033539 L in 1 CYLINDER
    4NDC:11043-011-04651 L in 1 CYLINDER
    5NDC:11043-011-05396 L in 1 CYLINDER
    6NDC:11043-011-06141 L in 1 CYLINDER
    7NDC:11043-011-07127425 L in 1 DEWAR
    8NDC:11043-011-08145692 L in 1 DEWAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14136501/01/1986
    Labeler - S. J. Smith Co., Inc. (170279462)
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.170279702manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.612212936manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.022100119manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.170279462manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.098385813manufacture