Label: OXYGEN gas

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    52557-001-02, 52557-001-03, 52557-001-04, 52557-001-06, view more
    52557-001-07, 52557-001-08, 52557-001-09, 52557-001-10, 52557-001-11, 52557-001-13, 52557-001-15, 52557-001-16, 52557-001-17, 52557-001-18, 52557-001-19, 52557-001-20, 52557-001-21, 52557-001-22, 52557-001-23
  • Packager: Cornerstone Mecial Services - Midwest, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 4, 2018

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

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, REFRIGERATED LIQUID USP

    UN1073

    Produced by Air Liquefaction

    CAS 7782-44-7

    FOR CHEMICAL EMERGENCY

    CALL CHEM-TREC 1-800-424-9300

    Manufactured by:

    CornerStone Medical Services

    Your Foundation for Health at Home

    CornerStone Medical

    Services-Midwest LLC

    4460 Lake Forest Dr., Ste 232

    Blue Ash, OH 45242

    888-574-0202

    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

    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.

    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:

    KEEP OUT OF REACH OF CHILDREN.

    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. oxygen1

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, REFRIGERATED LIQUID USP

    UN1073

    Produced by Air Liquefaction

    CAS 7782-44-7

    FOR CHEMICAL EMERGENCY

    CALL CHEM-TREC 1-800-424-9300

    Manufactured by:

    CornerStone Medical Services

    Your Foundation for Health at Home

    CornerStone Medical

    Services-Midwest LLC

    451 South High Street

    Akron, OH 44311

    888-367-0202

    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

    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.

    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:

    KEEP OUT OF REACH OF CHILDREN.

    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. oxygen2

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, REFRIGERATED LIQUID USP

    UN1073

    Produced by Air Liquefaction

    CAS 7782-44-7

    FOR CHEMICAL EMERGENCY

    CALL CHEM-TREC 1-800-424-9300

    Manufactured by:

    CornerStone Medical Services

    Your Foundation for Health at Home

    CornerStone Medical

    Services-Midwest LLC

    489 West Exchange St.

    Akron, OH 44302

    330-535-4481

    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

    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.

    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:

    KEEP OUT OF REACH OF CHILDREN.

    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. oxygen3

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP

    UN1072

    Produced by Air Liquefaction

    CAS 7782-44-7

    FOR CHEMICAL EMERGENCY

    CALL CHEM-TREC 1-800-424-9300

    Manufactured by:

    CornerStone Medical Service-Midwest LLC

    489 W Exchange St., Akron, OH 44302

    330-535-4481

    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.

    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: KEEP OUT OF REACH OF CHILDREN. MAY CAUSE OR INTENSIFY FIRE: OXIDIZER

    CONTAINS GAS UNDER PRESSURE: MAY EXPLODE.

    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 preventative 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.

    DO NOT REMOVE THIS PRODUCT LABEL oxygen4

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP

    UN1072

    Produced by Air Liquefaction

    CAS 7782-44-7

    FOR CHEMICAL EMERGENCY

    CALL CHEM-TREC 1-800-424-9300

    Manufactured by:

    CornerStone Medical Service-Midwest LLC

    489 W Exchange St., Akron, OH 44302

    330-535-4481

    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.

    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: KEEP OUT OF REACH OF CHILDREN. MAY CAUSE OR INTENSIFY FIRE: OXIDIZER

    CONTAINS GAS UNDER PRESSURE: MAY EXPLODE.

    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 preventative 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.

    DO NOT REMOVE THIS PRODUCT LABEL oxygen5

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52557-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52557-001-1537619 L in 1 DEWAR; Type 0: Not a Combination Product06/25/2010
    2NDC:52557-001-1633756 L in 1 DEWAR; Type 0: Not a Combination Product06/25/2010
    3NDC:52557-001-1729069 L in 1 DEWAR; Type 0: Not a Combination Product06/25/2010
    4NDC:52557-001-18255223 L in 1 DEWAR; Type 0: Not a Combination Product06/25/2010
    5NDC:52557-001-1917290 L in 1 DEWAR; Type 0: Not a Combination Product06/25/2010
    6NDC:52557-001-201 L in 1 DEWAR; Type 0: Not a Combination Product06/25/2010
    7NDC:52557-001-02113 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    8NDC:52557-001-03170 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    9NDC:52557-001-04170 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    10NDC:52557-001-06425 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    11NDC:52557-001-07622 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    12NDC:52557-001-08680 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    13NDC:52557-001-091699 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    14NDC:52557-001-103160 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    15NDC:52557-001-116900 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    16NDC:52557-001-131 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    17NDC:52557-001-2142 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    18NDC:52557-001-22225 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    19NDC:52557-001-238510 L in 1 CYLINDER; Type 0: Not a Combination Product06/25/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576706/25/2010
    Labeler - Cornerstone Mecial Services - Midwest, LLC (623726010)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cornerstone Medical Services dba Cornerstone Medical Services-Midwest LLC172858180manufacture(52557-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cornerstone Medical Services-midwest962760190manufacture(52557-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    CORNERSTONE MEDICAL SERVICES - MIDWEST, LLC963018986manufacture(52557-001)