Label: NITROUS OXIDE- nitrous oxide gas

  • NDC Code(s): 10736-017-01, 10736-017-02, 10736-017-03, 10736-017-04, view more
    10736-017-05, 10736-017-06
  • Packager: MEDICAL-TECHNICAL GASES, INC.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 7, 2018

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

  • PRINCIPAL DISPLAY PANEL

    DO NOT REMOVE THIS LABEL
    NITROUS OXIDE COMPRESSED USP
    UN1070
    CAS No. 10024-97-2 N2O
    CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION
    WARNING: HIGH PRESSURE OXIDIZING LIQUID AND GAS. VIGOROUSLY ACCELERATES COMBUSTION. CAN CAUSE RAPID SUFFOCATION. CAN CAUSE ANESTHETIC EFFECTS. MAY CAUSE FROSTBITE.
    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.
    WARNING: Inhalation of Nitrous Oxide without sufficient oxygen supply may be fatal or cause brain damage. Release of Nitrous Oxide will dilute the oxygen percentage in the atmosphere. Physiological responses due to Nitrous Oxide exposure and oxygen deficiency inhibit ability to safely respond when exposed to Nitrous Oxide concentration in excess of 10 percent.
    CAUTION: Avoid breathing gas. Store and use with adequate ventilation. Keep oil and grease away. Do not get liquid in eyes, on skin or clothing. Cylinder temperature should not exceed 125 F (52 C). Use only with equipment cleaned for Nitrous Oxide and rated for cylinder pressure. OPEN VALVE SLOWLY. USE IN ACCORDANCE WITH MED-TECH’S MATERIALS SAFETY DATA SHEET.
    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 immediate medical attention.
    MEDTECH Since 1961
    MEDICAL-TECHNICAL GASES, INC.
    20 Hall Street, Medford, MA 02155
    617-395-1946 FAX 617-395-9098 nitrous oxide

    Close
  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10736-017
    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 995 mL  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10736-017-01 988 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1963
    2 NDC:10736-017-02 1606 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1963
    3 NDC:10736-017-03 2379 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1963
    4 NDC:10736-017-04 3596 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1963
    5 NDC:10736-017-05 6909 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1963
    6 NDC:10736-017-06 9486 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1963
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA209989 01/01/1963
    Labeler - MEDICAL-TECHNICAL GASES, INC. (019481373)
    Establishment
    Name Address ID/FEI Business Operations
    MEDICAL-TECHNICAL GASES, INC. 019481373 manufacture(10736-017)
    Close