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

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 label

HELIUM OXYGEN MIXTURE
helium oxygen mixture gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:11054-032
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41)	HELIUM	700 mL in 1 L
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	300 mL in 1 L

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA authorized generic	NDA205843	01/03/2012

Labeler - Airgas Usa, LLC (078301808)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		003324498	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		006301766	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		032547507	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		072198059	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		079214355	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		079934743	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		620137799	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		790441885	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		827455879	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		879945632	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		946304797	manufacture(11054-032)

Name	Address	ID/FEI	Business Operations
Establishment
Airgas Usa, LLC		947401071	manufacture(11054-032)

Helium Oxygen Mixture 032

Helium/Oxygen Mix