Label: 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 October 12, 2020

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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

  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55404-002
    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:55404-002-01242 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
    2NDC:55404-002-02940 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
    3NDC:55404-002-031560 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
    4NDC:55404-002-043630 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
    5NDC:55404-002-054840 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
    6NDC:55404-002-0616550 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
    7NDC:55404-002-0715490 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20998901/01/1964
    Labeler - Lessors, Incorporated (041806169)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lessors, Incorporated041806159manufacture(55404-002)