Label: OXYGEN gas

  • NDC Code(s): 53452-001-01, 53452-001-02, 53452-001-03, 53452-001-04, view more
    53452-001-05, 53452-001-06, 53452-001-07, 53452-001-08, 53452-001-09, 53452-001-10, 53452-001-11
  • Packager: Dale Oxygen And Acetylene Service, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 10, 2023

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

  • PRINCIPAL DISPLAY PANEL

    REFRIGERATED LIQUID
    OXYGEN, REFRIGERATED LIQUID USP
    UN1073
    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
    DALE OXYGEN, INC.
    146 HORNER ST. JOHNSTOWN, PA 15902
    814-535-3594 image description

  • 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.
    DALE OXYGEN, INC.
    146 HORNER ST. JOHNSTOWN, PA 15902
    814-535-3594 image description

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53452-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53452-001-01420 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1963
    2NDC:53452-001-02690 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1963
    3NDC:53452-001-033160 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1963
    4NDC:53452-001-046900 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1963
    5NDC:53452-001-05165 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1963
    6NDC:53452-001-06249 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1963
    7NDC:53452-001-07210 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1963
    8NDC:53452-001-082265 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1963
    9NDC:53452-001-09200 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1963
    10NDC:53452-001-1080 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1963
    11NDC:53452-001-1130 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1963
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576701/01/1963
    Labeler - Dale Oxygen And Acetylene Service, Inc (014256960)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dale Oxygen And Acetylene Service, Inc014256960manufacture(53452-001)