Label: OXYGEN gas

  • NDC Code(s): 81676-001-01, 81676-001-02, 81676-001-03, 81676-001-04, view more
    81676-001-05
  • Packager: Joerns LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 6, 2023

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  • Oxygen

    OXYGEN,

    COMPRESSED USP

    UN 1072

    OXYGEN 2(R-K14) XXXXXX

    C.A.S. 7782-44-7

    Joerns®

    19211 Chennault Way Suite C • Gaithersburg, MD 20879

    800-528-1001

    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. DO NOT REMOVE THIS PRODUCT LABEL.

    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.

    SIZE CONTENTS                                 SIZE CONTENTS

    __ M6   170 Liters                            __ E        682 Liters

    __ C       248 Liters                            __ H       6910 Liters

    __ D       415 Liters                            __ Other   ____ Liters

    Joerns Oxygen

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81676-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81676-001-01170 L in 1 CYLINDER; Type 0: Not a Combination Product03/08/2021
    2NDC:81676-001-02248 L in 1 CYLINDER; Type 0: Not a Combination Product03/08/2021
    3NDC:81676-001-03415 L in 1 CYLINDER; Type 0: Not a Combination Product03/08/2021
    4NDC:81676-001-04682 L in 1 CYLINDER; Type 0: Not a Combination Product03/08/2021
    5NDC:81676-001-056910 L in 1 CYLINDER; Type 0: Not a Combination Product03/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20602303/08/2021
    Labeler - Joerns LLC (097260594)
    Establishment
    NameAddressID/FEIBusiness Operations
    Joerns LLC097260594manufacture(81676-001)