Label: OXYGEN gas

  • NDC Code(s): 33335-001-01, 33335-001-02, 33335-001-03, 33335-001-04, view more
    33335-001-05, 33335-001-06, 33335-001-07, 33335-001-08, 33335-001-09, 33335-001-10
  • Packager: WELSCO, INC.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 17, 2022

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  • PRINCIPAL DISPLAY PANEL

    OXYGEN, COMPRESSED USP UN1072 PRODUCED BY AIR LIQUIFACTION OXYGEN 2
    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 INTENCIFY FIRE; OXYDIZER. 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
    DISTRIBUTED BY: WELSCO 9006 CRYSTAL HILL ROAD NORTH LITTLE ROCK, AR 72113 . 501-771-1204 oxygen one

  • PRINCIPAL DISPLAY PANEL

    REFRIGERATED LIQUID OXYGEN, REFRIGERATED LIQUID USP UN1073 OXYGEN 2
    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 filled 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; OXYDIZER. 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.
    DISTRIBUTED BY: WELSCO 9006 CRYSTAL HILL ROAD NORTH LITTLE ROCK, AR 72113 . 501-771-1204 oxygen two

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:33335-001
    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:33335-001-017929 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1941
    2NDC:33335-001-02708 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1941
    3NDC:33335-001-03663 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1941
    4NDC:33335-001-04408 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1941
    5NDC:33335-001-05198 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1941
    6NDC:33335-001-06283 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1941
    7NDC:33335-001-0728.31 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1941
    8NDC:33335-001-08180 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1941
    9NDC:33335-001-09160 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1941
    10NDC:33335-001-1026497 L in 1 TANK; Type 0: Not a Combination Product01/01/1941
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576701/01/1941
    Labeler - WELSCO, INC. (006357420)
    Establishment
    NameAddressID/FEIBusiness Operations
    WELSCO, INC.006357420manufacture(33335-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    WELSCO, INC.032494783manufacture(33335-001)