Label: NITROUS OXIDE- nitrous oxide gas

  • NDC Code(s): 55050-0018-1, 55050-0018-2, 55050-0018-3
  • Packager: Holston Gases, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 23, 2019

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  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE USP UN1070 NON-FLAMMABLE GAS 2 OXIDIZER 5.1
    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. CONTENTS: LTRS: CU.FT.
    HOLSTON GASES 545 W. BAXTER AVENUE KNOXVILLE, TN 37921 865-573-1917 nitrous oxide one

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  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55050-0018
    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 99 kg  in 100 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55050-0018-1 2.9 kg in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1958
    2 NDC:55050-0018-2 9.07 kg in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1958
    3 NDC:55050-0018-3 25.4 kg in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1958
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA206009 01/01/1958
    Labeler - Holston Gases, Inc (034697276)
    Registrant - Holston Gases, Inc (034697276)
    Establishment
    Name Address ID/FEI Business Operations
    Holston Gases, Inc 034697276 manufacture(55050-0018)
    Establishment
    Name Address ID/FEI Business Operations
    Holston Gases, Inc 829338115 manufacture(55050-0018)
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