Label: NITROUS OXIDE- nitrous oxide gas

  • NDC Code(s): 46123-006-01, 46123-006-02, 46123-006-03, 46123-006-04, view more
    46123-006-05, 46123-006-06, 46123-006-07, 46123-006-08, 46123-006-09, 46123-006-10, 46123-006-11
  • Packager: Roberts Oxygen Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 30, 2016

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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 USP 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 USP and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and the hazards, contraindications and side effects and the precautions to be taken. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CUASE 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 fitting free from grease and oil. 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. Use a back flow preventative 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°C (125°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 PRODUCT LABEL.
    Roberts Oxygen Company, Inc
    PO BOX 5507 Rockville, MD 20855
    301-948-8100

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  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-006
    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:46123-006-01 247 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    2 NDC:46123-006-02 990 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    3 NDC:46123-006-03 1232 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    4 NDC:46123-006-04 1590 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    5 NDC:46123-006-05 2464 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    6 NDC:46123-006-06 3710 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    7 NDC:46123-006-07 4944 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    8 NDC:46123-006-08 7391 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    9 NDC:46123-006-09 7570 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    10 NDC:46123-006-10 13797 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    11 NDC:46123-006-11 16066 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA206009 01/01/1967
    Labeler - Roberts Oxygen Company, Inc. (042646877)
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