OXYGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]

OXYGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]
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NDC 53425-001-01, 53425-001-02, 53425-001-03, 53425-001-04
Set ID c21fefc5-2696-4268-b88c-452a9abb7012
Category HUMAN PRESCRIPTION DRUG LABEL
Packager IWS Gas and Supply of Texas, LTD
Generic Name
Product Class
Product Number
Application Number NDA205712
  • PRINCIPAL DISPLAY PANEL

    OXYGEN REFRIGERATED LIQUID, USP   OXYGEN 2
    UN 1073 CRYOGENIC LIQUID  Produced by Air Liquefaction
    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION
    WARNING! EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE.
    For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, RX only.
    WARNING! Uninterrupted use of high concentrations of oxygen over 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. Keep oil, grease, and combustibles away. Use only with equipment cleaned for oxygen service. Store and use with adequate ventilation. Do not get liquid in eyes, on skin or clothing. For liquid withdrawal, wear face shield and gloves. Do not drop. Use hand truck for container movement. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Use in accordance with Material Safety Data Sheet.
    WARNING: Cautions Federal Law Prohibits Dispensing without Prescription.
    FIRST AID
    IN CASE OF FROSTBITE, obtain medical treatment immediately.
    PLEASE REFER TO THE MATERIAL SAFETY DATA SHEET FOR SAFETY AND PRODUCT INFORMATION.
    Company Name:
    Lot Number:
    Contents:
    Expiration Date:
    DO NOT REMOVE THIS PRODUCT LABEL oxygen one

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP   OXYGEN 2
    UN1072
    For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. WARNING: SECURE ALL CYLINDERS WHEN IN STORAGE AND IN USE. 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. Use in accordance with Material Safety Data Sheet and safety precautions recommended by the supplier. FIRST AID: IF INHALED, remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. Call a physician.
    WARNING: FEDERAL LAW PROHIBITS DISPENSING THIS PRODUCT WITHOUT PRESCRIPTION. Produced by air liquefaction. DO NOT REMOVE THIS PRODUCT LABEL.
    IWS GAS AND SUPPLY OF TEXAS, LTD
    4117 Fair Drive
    Pasadena, TX 77507
    EMERGENCY PHONE: 713-691-4900

    Net Contents: oxygen two

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP

    UN1072

    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. 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.

    GAS AND SUPPLY

    105 Rothrock Drive, Bldg. 2

    Longview, TX 75602

    903-653-0999

    CONTENTS:

    LTRS:

    CU.FT. oxygen one

  • PRINCIPAL DISPLAY PANEL

    OXYGEN, REFRIGERATED LIQUID USP

    UN1073

    ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.

    DO NOT CHANGE OR FORCE FIT CONNECTIONS.

    CONTENTS: LTRS: CU.FT.

    WARNING: USP For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical application, 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.

    DANGER: MAY CAUSE OF 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.

    CAS: 7782-44-7

    DO NOT REMOVE THIS PRODUCT LABEL.

    GAS AND SUPPLY

    105 Rothrock Drive, Bldg. 2

    Longview, TX 75602

    903-653-0999 oxygen two

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53425-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN995 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53425-001-017108 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    2NDC:53425-001-02708 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    3NDC:53425-001-03425 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    4NDC:53425-001-04172365 L in 1 DEWAR; Type 0: Not a Combination Product07/19/2010
    5NDC:53425-001-05198 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    6NDC:53425-001-063228 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    7NDC:53425-001-073539 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    8NDC:53425-001-086456 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    9NDC:53425-001-097249 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    10NDC:53425-001-107957 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    11NDC:53425-001-118693 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    12NDC:53425-001-129543 L in 1 CYLINDER; Type 0: Not a Combination Product07/19/2010
    13NDC:53425-001-13180 L in 1 DEWAR; Type 0: Not a Combination Product07/19/2010
    14NDC:53425-001-14200 L in 1 DEWAR; Type 0: Not a Combination Product07/19/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20571207/19/2010
    Labeler - IWS Gas and Supply of Texas, LTD (963374793)
    Establishment
    NameAddressID/FEIBusiness Operations
    IWS GAS AND SUPPLY OF TEXAS, LTD118170808manufacture(53425-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    IWS Gas and Supply of Texas, LTD963374793manufacture(53425-001)

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