Label: CARBON DIOXIDE-AIR MIXTURE gas

  • NDC Code(s): 46123-115-01, 46123-115-02, 46123-115-03, 46123-115-04, view more
    46123-115-05
  • Packager: Roberts Oxygen Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 12, 2021

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  • PRINCIPAL DISPLAY PANEL

    COMPRESSED GAS, N.O.S.
    (% AIR, USP % CARBON DIOXIDE, USP)
    UN1956
    Rx only. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and if familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY INCREASE RESPIRATION AND HEARTRATE. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. Do not handle until all safety precautions have been read and understood.
    Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for the cylinder pressure. 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. FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
    CAS: AIR 132259-10-0, CARBON DIOXIDE 124-38-9 DO NOT REMOVE THIS PRODUCT LABEL.
    Roberts Oxygen Company, Inc.
    PO Box 5507 Rockville, MD 20855
    301-948-8100 air carbon dioxide mix

  • INGREDIENTS AND APPEARANCE
    CARBON DIOXIDE-AIR MIXTURE 
    carbon dioxide-air mixture gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-115
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBON DIOXIDE (UNII: 142M471B3J) (CARBON DIOXIDE - UNII:142M471B3J) CARBON DIOXIDE50 mL  in 1 L
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN210 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    NITROGEN (UNII: N762921K75)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46123-115-01651 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1966
    2NDC:46123-115-02991 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1966
    3NDC:46123-115-035405 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1966
    4NDC:46123-115-046060 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1966
    5NDC:46123-115-056900 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1966
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584901/01/1966
    Labeler - Roberts Oxygen Company, Inc. (042646877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.020325953manufacture(46123-115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.788511095manufacture(46123-115)