Label: OXYGEN 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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  • OXYGEN COMPRESSED LABEL

    OXYGEN COMPRESSED U.S.P.  UN 1072  OXYGEN-2

    FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY. 

    NET CONTENTS:____________________________

    SHOULDER LABEL

  • PRODUCT WARNINGS AND PRECAUTIONS

    WARNING: SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE.  UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON OXYGEN CONTENT OF ARTERIAL BLOOD MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING, UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.  USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEETS AND SAFETY PRECAUTIONS RECOMMENDED BY THE SUPPLIER. 

    WARNING: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.  PRODUCED BY AIR LIQUEFACTION.  DO NOT REMOVE THIS PRODUCT LABEL.

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43314-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43314-001-01170 L in 1 CYLINDER
    2NDC:43314-001-02426 L in 1 CYLINDER
    3NDC:43314-001-03675 L in 1 CYLINDER
    4NDC:43314-001-043472 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/2003
    Labeler - Sound Oxygen Service, Inc. (623431843)
    Registrant - Sound Oxygen Service, Inc. (623431843)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sound Oxygen Service, Inc.623431843manufacture