Label: NITROUS OXIDE gas

  • NDC Code(s): 46123-007-01
  • Packager: Roberts Oxygen Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 19, 2020

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  • PRINCIPAL DISPLAY PANEL

    NITROUS
    OXIDE,
    REFRIGERATED
    LIQUID
    USP
    UN2201
    NON-FLAMMABLE GAS 2
    OXIDIZER 5.1
    Roberts Oxygen Company, Inc
    P.O. BOX 5507 Rockville, MD 20855
    301-948-8100
    ↑ALWAYS KEEP CONTAINER IN UPRIGHT POSITION↑
    WARNING:
    Rx Only. Administration of Nitrous Oxide USP 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 Nitrous Oxide USP and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and the hazards, contraindications and side effects and the precautions to be taken. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. MAY CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. 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 fitting free from grease and oil. Avoid breathing gas. 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 preventative 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. Avoid spills. Do not walk or roll equipment over spills. Close valve after each use and when empty. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or doctor/physician if you feel unwell. IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.
    CAS: 10024-97-2 DO NOT REMOVE THIS PRODUCT LABEL.

    image of dewar label

  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-007
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46123-007-0191453 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1967
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20600901/01/1967
    Labeler - Roberts Oxygen Company, Inc. (042646877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.791818008manufacture(46123-007)