Label: NITROUS OXIDE gas

  • NDC Code(s): 12213-593-11, 12213-593-12, 12213-593-13, 12213-593-28, view more
    12213-593-37, 12213-593-58
  • Packager: NEXAIR, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 1, 2020

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    REFRIGERATED LIQUID

    NITROUS OXIDE, REFRIGERATED LIQUID, USP

    UN2201

    CAS: 10024-97-2

    LOT #

    NET CONTENTS

    Part # C.F Liters

    LQ NO-USP-L1 3519 99,654

    RX Only

    WARNING: Administration of Nitrous Oxide 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 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 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 fittings 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 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. Avoid spills. Do not walk on 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.

    WARNING: This product contains a chemical known to the state of California to cause birth defects or other reproductive harm.

    DO NOT REMOVE THIS PRODICT LABEL.

    Distributed by nexAir

    nexAir, LLC www.nexAir.com

    1350 Concourse Ave., Suite 103 Memphis, TN 38104

    888-639-2474 nitrous oxide liquid

  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE USP

    UN1070

    DO NOT REMOVE THIS LABEL

    RX only. WARNING: Administration of Nitrous Oxide 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 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 CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY CAUSE FROSTBITE. 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. Avoid breathing gas. Do not get in eyes, on skin, or on clothing. 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. 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. WARNING: This product contains a chemical know to the state of California to cause birth defects or other reproductive harm. CAS: 10024-97-2

    Distributed by nexAir

    nexAir, LLC www.nexAir.com

    1350 Concourse Ave., Suite 103 Memphis, TN 38104

    888-639-2474

    LOT #:

    PART #:

    C.F. LITERS: nitrous oxide

  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12213-593
    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:12213-593-13986 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    2NDC:12213-593-581577 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    3NDC:12213-593-114928 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    4NDC:12213-593-377885 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    5NDC:12213-593-1213798 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    6NDC:12213-593-2899647 L in 1 CYLINDER; Type 0: Not a Combination Product06/01/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20600906/01/1996
    Labeler - NEXAIR, LLC (927024422)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXAIR, LLC010263301manufacture(12213-593)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXAIR, LLC927024422manufacture(12213-593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexair, LLC969017086manufacture(12213-593)