Label: NITROUS OXIDE gas

  • NDC Code(s): 46362-003-01, 46362-003-02, 46362-003-03, 46362-003-04, view more
    46362-003-05, 46362-003-06, 46362-003-07
  • Packager: Red Ball Oxygen Co., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 6, 2026

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  • PRINCIPAL DISPLAY PANEL

    NITROUS OXIDE USP

    UN1070

    DO NOT REMOVE THIS LABEL.

    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. Obtain, read and follow all safety instructions before use. Keep away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Avoid breathing contents. Do not get in eyes, on skin, or on clothing. Use and store only outdoors or in a well-ventilated place. Wear protective gloves, protective clothing, and either eye or face protection. In case of fire: Stop leak if safe to do so. Store locked up. Dispose of contents/container in accordance with container supplier/owner instructions. Use a back flow preventive device in the piping. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment cleaned for oxygen service. 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. Get medical help if you feel unwell. IF ON SKIN: Immediately thaw frosted parts with lukewarm water. Do not rub affected area. Get emergency medical help immediately. CAS: 10024-97-2

    WARNING: This product can expose you to chemicals including Nitrous Oxide, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

    RED BALL OXYGEN

    Red Ball Oxygen Co, Inc.

    609 North Market Street

    Shreveport, LA 71107 318-425-3211

    CONTENTS LITERS nitrous oxide 2026

  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46362-003
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE992 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46362-003-01300 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    2NDC:46362-003-024929 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    3NDC:46362-003-031590 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    4NDC:46362-003-041591 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    5NDC:46362-003-0513846 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    6NDC:46362-003-062733 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    7NDC:46362-003-07959 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1986
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20600901/01/1986
    Labeler - Red Ball Oxygen Co., Inc. (049213267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Red Ball Oxygen Co., Inc.049213267manufacture(46362-003)