Label: NITROUS OXIDE OXYGEN MIX gas

  • NDC Code(s): 46123-700-01
  • Packager: Roberts Oxygen Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 17, 2025

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  • PRINCIPAL DISPLAY PANEL

    COMPRESSED GAS, OXIDIZING, N.O.S.

    ( %

    %

    %)

    UN3156

    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 is 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. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY INCREASE RESPIRATION AND HEART RATE. 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. 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. FIRST AID: IF ACCIDENTALLY INHALED. Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.

    CAS: DO NOT REMOVE THIS PRODUCT LABEL.

    Roberts Oxygen Company, Inc.

    PO Box 5507 Rockville, MD 20855

    301-948-8100 n2o and o2 mix 2025

  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE OXYGEN MIX 
    nitrous oxide oxygen mix gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-700
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE500 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    OXYGEN (UNII: S88TT14065) 500 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46123-700-014139 L in 1 CYLINDER; Type 0: Not a Combination Product11/17/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20600911/17/2025
    Labeler - Roberts Oxygen Company, Inc. (042646877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.791818008manufacture(46123-700)