Label: NITROUS OXIDE- nitrous oxide gas

  • NDC Code(s): 34057-010-01, 34057-010-02, 34057-010-03, 34057-010-04, view more
    34057-010-05, 34057-010-06
  • Packager: Oxarc, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 5, 2018

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  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE USP NON-FLAMMABLE GAS 2 OXIDIZER 5.1 UN1070
    OXARC 4003 E BROADWAY SPOKANE, WA 99202 1-800-536-9272 www.oxarc.com
    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 PESSURE; MAY EXPLODE IF HEATED. MAY CUASE 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 put 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 degrees C (125 degrees 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. CAS: 10024-97-2 DO NOT REMOVE THIS LABEL
    Size Contents Size Contents AND 1.74 Liters 50# 18.51 Liters ANE 2.36 Liters 64# 23.69 Liters 20# 7.4 Liters 75# 27.76 Liters Other Liters nitrousoxide1

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  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:34057-010
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE 990 mL  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:34057-010-01 906 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977
    2 NDC:34057-010-02 1557 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977
    3 NDC:34057-010-03 4814 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977
    4 NDC:34057-010-04 12063 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977
    5 NDC:34057-010-05 15461 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977
    6 NDC:34057-010-06 18123 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1977
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA206009 01/01/1977
    Labeler - Oxarc, Inc. (045704400)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 005126375 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 023413843 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 027588227 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 122450901 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 169175390 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 603889721 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 609558051 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 611947086 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 612414425 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 783197932 manufacture(34057-010)
    Establishment
    Name Address ID/FEI Business Operations
    Oxarc, Inc. 859257297 manufacture(34057-010)
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