Label: OXYGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 19, 2022

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 OXIDIZING REFRIGERATED LIQUIDS 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. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Use only equipment of compatible materials of construction. Open valve slowly. Use only with equipment cleaned for oxygen service. Always keep container in upright position. DO NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. 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 oxygen

  • 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. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Use only equipment of compatible materials of construction. Open valve slowly. Use only with equipment cleaned for oxygen service. 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.

    AMERICAN GASES CORP.

    2217 NORTH DELANY RD. WAUKEGAN, IL 60087

    847-336-4734 oxygen two

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:82606-001
    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:82606-001-01169 L in 1 CYLINDER; Type 0: Not a Combination Product04/15/2022
    2NDC:82606-001-02254 L in 1 CYLINDER; Type 0: Not a Combination Product04/15/2022
    3NDC:82606-001-03420 L in 1 CYLINDER; Type 0: Not a Combination Product04/15/2022
    4NDC:82606-001-04690 L in 1 CYLINDER; Type 0: Not a Combination Product04/15/2022
    5NDC:82606-001-051132 L in 1 CYLINDER; Type 0: Not a Combination Product04/15/2022
    6NDC:82606-001-063470 L in 1 CYLINDER; Type 0: Not a Combination Product04/15/2022
    7NDC:82606-001-074229 L in 1 CYLINDER; Type 0: Not a Combination Product04/15/2022
    8NDC:82606-001-087107 L in 1 CYLINDER; Type 0: Not a Combination Product04/15/2022
    9NDC:82606-001-099542 L in 1 CYLINDER; Type 0: Not a Combination Product04/15/2022
    10NDC:82606-001-10180 L in 1 TANK; Type 0: Not a Combination Product04/15/2022
    11NDC:82606-001-11230 L in 1 TANK; Type 0: Not a Combination Product04/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576704/15/2022
    Labeler - AMERICAN GASES CORPORATION (796515054)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMERICAN GASES CORPORATION796515054manufacture(82606-001)