Label: OXYGEN gas

  • NDC Code(s): 57924-001-01, 57924-001-02, 57924-001-03, 57924-001-04, view more
    57924-001-05, 57924-001-06, 57924-001-07, 57924-001-08
  • Packager: Ross Medical Supply Co. Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 15, 2023

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  • PRINCIPAL DISPLAY PANEL

    Ross Medical HP Oxygen Label

    OXYGEN,
    COMPRESSED

    USP

    UN1072

    PRODUCED BY AIR LIQUEFACTION

    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. 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 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 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
    RepresentativeLotSticker

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57924-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN991 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57924-001-01113 L in 1 CYLINDER; Type 0: Not a Combination Product01/03/2011
    2NDC:57924-001-02169 L in 1 CYLINDER; Type 0: Not a Combination Product01/03/2011
    3NDC:57924-001-03254 L in 1 CYLINDER; Type 0: Not a Combination Product01/03/2011
    4NDC:57924-001-04424 L in 1 CYLINDER; Type 0: Not a Combination Product01/03/2011
    5NDC:57924-001-05679 L in 1 CYLINDER; Type 0: Not a Combination Product01/03/2011
    6NDC:57924-001-063539 L in 1 CYLINDER; Type 0: Not a Combination Product01/03/2011
    7NDC:57924-001-076059 L in 1 CYLINDER; Type 0: Not a Combination Product01/03/2011
    8NDC:57924-001-086909 L in 1 CYLINDER; Type 0: Not a Combination Product01/03/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/03/2011
    Labeler - Ross Medical Supply Co. Inc. (063249718)