Label: NITROUS OXIDE- nitrous oxide gas

  • NDC Code(s): 55404-002-01, 55404-002-02, 55404-002-03, 55404-002-04, view more
    55404-002-05, 55404-002-06, 55404-002-07
  • Packager: Lessors, Incorporated
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 5, 2018

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  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE, USP
    UN1070
    NON-FLAMMABLE 2 OXIDIZER 5.1

    34436 (R04/05)
    Rx only. WARNING: Administration of Nitrous Oxide may be hazardous or contraindicated. For use 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.

    WARNING: HIGH PRESSURE OXIDIZING LIQUID GAS. VIGOROUSLY ACCELERATES COMBUSTION. CAN CAUSE RAPID SUFFOCATION. CAN CAUSE ANESTHETIC EFFECTS. MAY CAUSE FROSTBITE. Avoid breathing gas. Store and use with adequate ventilation. Keep oil and grease away. Use only with equipment cleaned for oxygen and rated for cylinder pressure. Do not get liquid in eyes, on skin or clothing. Cylinder temperature should not exceed 52oC(125oF). Open valve slowly. Close valve after each use and when empty. use a back flow preventive device in the piping. Use in accordance with the Material Safety Data Sheet (MSDS).

    FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician. IN CASE OF FROSTBITE, obtain medical treatment immediately. CAS: 10024-97-2
    DO NOT REMOVE THIS PRODUCT LABEL.
    LESSORS, INC. 1300 N. GENESEE RD BURTON, MI 48509 810-742-2302 nitrousoxide

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  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55404-002
    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:55404-002-01 242 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1964
    2 NDC:55404-002-02 940 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1964
    3 NDC:55404-002-03 1560 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1964
    4 NDC:55404-002-04 3630 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1964
    5 NDC:55404-002-05 4840 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1964
    6 NDC:55404-002-06 16550 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1964
    7 NDC:55404-002-07 15490 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1964
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA209989 01/01/1964
    Labeler - Lessors, Incorporated (041806169)
    Establishment
    Name Address ID/FEI Business Operations
    Lessors, Incorporated 041806159 manufacture(55404-002)
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