Label: HELIUM OXYGEN MIXTURE gas
- NDC Code(s): 11054-032-01, 11054-032-02
- Packager: Airgas Usa, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
Drug Label Information
Updated October 5, 2023
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Helium/Oxygen Mix
UN1956
COMPRESSED GASES, N.O.S.
(HELIUM, OXYGEN)
Components:
% HELIUM USP CAS: 7740-59-7
% OXYGEN USP CAS: 7782-44-7
LOT NUMBER
NET CONTENTS
CAUTION! HIGH-PRESSURE GAS. MAY ACCELERTE COMBUSTION CONCENTRATIONS BELOW 19.5% OXYGEN CAN CAUSE SUFFOCATION. MAY CAUSE DIZZINESS AND DROWSINESS.
Keep oil, grease and combustibles away. Keep away from heat, sparks, and flame. Open valve slowly. Store and use with adequate ventilation. Use with equipment rated for cylinder pressure and cleaned for oxygen service. Cylinder temperature should not exceed 125°F (52°C). Close valve when not in use; keep closed even when empty. Always secure cylinder. Install cap, if provided, when not in use. Use a backflow prevention device in any piping. Use per MSDS provided and Praxair safety practices booklets P-3499 and P-14-153; obtain from your local supplier.
RX ONLY
WARNING! Administration this gas mixture 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 gas mixtures 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.
IN CASE OF EMERGENCY: CALL 1-800-645-4633
Copyright 1997-1998, 2003, 2007 Praxair Technology, Inc.
DO NOT REMOVE THIS LABEL
Praxair, the flowing airstream design and Medipure are trademarks of Praxair Technology, Inc. DISTRIBUTED BY PRAXAIR, INC, DANBURY, CT 06810-5113
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INGREDIENTS AND APPEARANCE
HELIUM OXYGEN MIXTURE
helium oxygen mixture gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11054-032 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM 700 mL in 1 L OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 300 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11054-032-01 3539 L in 1 CYLINDER; Type 0: Not a Combination Product 01/03/2012 2 NDC:11054-032-02 5663 L in 1 CYLINDER; Type 0: Not a Combination Product 01/03/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA205843 01/03/2012 Labeler - Airgas Usa, LLC (078301808) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 003324498 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 006301766 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 032547507 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 072198059 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 079214355 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 079934743 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 620137799 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 790441885 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 827455879 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 879945632 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 946304797 manufacture(11054-032) Establishment Name Address ID/FEI Business Operations Airgas Usa, LLC 947401071 manufacture(11054-032)