OXYGEN GAS [S. J. SMITH CO., INC.]

OXYGEN GAS [S. J. SMITH CO., INC.]
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NDC 11043-001-01, 11043-001-02, 11043-001-03, 11043-001-04, 11043-001-05, 11043-001-06, 11043-001-07, 11043-001-08
Set ID 89544705-5d9d-4595-8870-fa46c9c14af2
Category HUMAN PRESCRIPTION DRUG LABEL
Packager S. J. Smith Co., Inc.
Generic Name
Product Class
Product Number
Application Number NDA205767
  • 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

    563-324-5237 oxygen 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

    563-324-5237 oxygen 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

    563-324-5237 oxygen 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

    563-324-5237 oxygen four

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11043-001
    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:11043-001-01154326 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1986
    2NDC:11043-001-027107 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    3NDC:11043-001-033539 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    4NDC:11043-001-04651 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    5NDC:11043-001-05396 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    6NDC:11043-001-06141 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    7NDC:11043-001-07127425 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1986
    8NDC:11043-001-08145692 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1986
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576701/01/1986
    Labeler - S. J. Smith Co., Inc. (170279462)
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.022100119manufacture(11043-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.098385813manufacture(11043-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.170279462manufacture(11043-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.170279702manufacture(11043-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    S. J. Smith Co., Inc.612212936manufacture(11043-001)

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