Label: NITROUS OXIDE- nitrous oxide gas

  • NDC Code(s): 10927-102-09, 10927-102-10, 10927-102-11, 10927-102-12, view more
    10927-102-13, 10927-102-14, 10927-102-15
  • Packager: PURITY CYLINDER GASES INC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 31, 2018

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  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE USP
    UN1070
    Rx only. 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. DANGER: MAY CAUSE OR INTENSIF FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCIATION. 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 fittings 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 preventive 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 POISION CENTER or doctor/physician if you feel unwell. IF ON SKIN: That frosted parts with lukewarm water. Do not rub affected are. Get immediate medical advice/attention. WARNING: This product contains a chemical known to the state of California to cause birth defects or other reproductive harm. CAS: 10024-97-2
    PURITY CYLINDER GASES, INC.
    2580 28TH ST SW, WYOMING, MI 49519
    616-532-2375 nitrous oxide

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  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE USP
    UN1070
    Rx only. 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. DANGER: 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. 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 fittings free from grease and oil. Avoid breathing gas. Do not get in eyes, on skin, or on clothing. Use and store only outdoors in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive 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 POISION 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. WARNING: This product contains a chemical known for the state of California to cause birth defects or other reproductive harm. CAS: 10324-97-2
    PURITY CYLINDER GASES, INC.
    2580 28TH ST SW, WYOMING, MI 49519
    616-532-2375 nitrous oxide 2018

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  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10927-102
    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 L  in 100 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10927-102-09 246 L in 1 CYLINDER; Type 0: Not a Combination Product 10/20/2038
    2 NDC:10927-102-10 1232 L in 1 CYLINDER; Type 0: Not a Combination Product 10/20/2038
    3 NDC:10927-102-11 1725 L in 1 CYLINDER; Type 0: Not a Combination Product 10/20/2038
    4 NDC:10927-102-12 2464 L in 1 CYLINDER; Type 0: Not a Combination Product 10/20/2038
    5 NDC:10927-102-13 4928 L in 1 CYLINDER; Type 0: Not a Combination Product 10/20/2038
    6 NDC:10927-102-14 7392 L in 1 CYLINDER; Type 0: Not a Combination Product 10/20/2038
    7 NDC:10927-102-15 13798 L in 1 CYLINDER; Type 0: Not a Combination Product 10/20/2038
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA209989 10/20/1938
    Labeler - PURITY CYLINDER GASES INC (065878860)
    Establishment
    Name Address ID/FEI Business Operations
    PURITY CYLINDER GASES INC 120042374 manufacture(10927-102)
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