Label: NITROUS OXIDE gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 1, 2010

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  • NITROUS OXIDE COMPRESSED LABEL

    NITROUS OXIDE, COMPRESSED - NON-FLAMMABLE GAS - 2 - OXIDIZER USP UN 1070

    WARNING SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE.

    CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION

    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.

    NITROUS LABEL

  • GENERAL WARNINGS AND PRECAUTIONS

    WARNING: HIGH PRESSURE OXIDIZING LIQUID AND GAS.  VIGOROUSLY ACCELERATES COMBUSTION.  CAN CAUSE RAPID SUFFOCATION.  CAN CAUSE ANESTHETIC EFFECTS.  MAY CAUSE FROSTBITE.  AVOID BREATHING GAS.  STORE AND USE WITH ADEQUATE VENTILATION. KEEP OIL AND GREASE AWAY.  USE ONLY WITH EQUIPMENT CLEANED FOR NITROUS OXIDE AND RATED FOR CYLINDER PRESSURE.  DO NOT GET LIQUID IN EYES ON SKIN OR CLOTHING.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 125 F (52 C)  OPEN VALVE SLOWLY  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)  NOTE: SUCK-BACK INTO CYLINDER MAY CAUSE RUPTURE.  ALWAYS USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  FIRST AID: IF INHALED REMOVE TO FRESH AIR.  IF NOT BREATHING GIVE ARTIFICIAL RESPIRATION.  IF BREATHING DIFFICULT GIVE OXYGEN.  CALL A PHYSICIAN.  IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.

    DO NOT REMOVE THIS PRODUCT LABEL

  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55050-0008
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE99 kg  in 100 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55050-0008-12.90 kg in 1 CYLINDER
    2NDC:55050-0008-29.07 kg in 1 CYLINDER
    3NDC:55050-0008-325.4 kg in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1958
    Labeler - Holston Gases, Inc (034697276)
    Registrant - Holston Gases, Inc (034697276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holston Gases, Inc034697276manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Holston Gases, Inc829338115manufacture