Label: NITROUS OXIDE- nitrous oxide gas

  • NDC Code(s): 52086-003-01, 52086-003-02, 52086-003-03, 52086-003-04, view more
    52086-003-05
  • Packager: Helget Gas Products
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 19, 2017

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  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE USP
    UN1070
    CAS: 10024-97-2
    DO NOT REMOVE THIS LABEL
    DANGER
    RX Only
    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 precautions to be taken.
    MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY CAUSE FROSTBITE.
    Caution: Do not handle until all safety precautions have been read and understood. Keep/store away from combustible materials, clothing. Keep valves and fittings free from oil and grease. Avoid breathing gas. Do not get 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. Only use equipment rated for cylinder pressure. Use a back flow prevention device in the piping. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Cylinder temperature should not exceed 52 C (125 F). Use in accordance with Safety Data Sheet for this product.
    First Air: 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.
    HELGET GAS PRODUCTS 4150 S 87TH STREET, OMAHA, NE 68127 866-814-1554nitrous oxide 1

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  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52086-003
    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 99.5 L  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52086-003-01 13500 L in 1 CYLINDER; Type 0: Not a Combination Product 09/08/1983
    2 NDC:52086-003-02 4900 L in 1 CYLINDER; Type 0: Not a Combination Product 09/08/1983
    3 NDC:52086-003-03 1150 L in 1 CYLINDER; Type 0: Not a Combination Product 09/08/1983
    4 NDC:52086-003-04 950 L in 1 CYLINDER; Type 0: Not a Combination Product 09/08/1983
    5 NDC:52086-003-05 200 L in 1 CYLINDER; Type 0: Not a Combination Product 09/08/1983
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA206014 09/08/1983
    Labeler - Helget Gas Products (109096339)
    Establishment
    Name Address ID/FEI Business Operations
    Helget Gas Products 109096339 manufacture(52086-003)
    Establishment
    Name Address ID/FEI Business Operations
    Helget Gas Products 046676685 manufacture(52086-003)
    Establishment
    Name Address ID/FEI Business Operations
    Helget Gas Products 118597488 manufacture(52086-003)
    Establishment
    Name Address ID/FEI Business Operations
    Helget Gas Products 078610962 manufacture(52086-003)
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