HELIUM OXYGEN MIXTURE gas

Helium Oxygen mixture by

Drug Labeling and Warnings

Helium Oxygen mixture by is a Prescription medication manufactured, distributed, or labeled by Praxair Distribution, Inc., Praxair Distribution, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

UN3156

COMPRESSED GAS,

OXIDIZING, N.O.S.

(OXYGEN, HELIUM)

% HELIUM USP CAS: 7440-59-7

% OXYGEN USP CAS: 7782-44-7

NET CONTENTS

LOT NUMBER

WARNING! HIGH-PRESSURE, OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION.

Keep oil, grease, and combustibles away. Store and use with adequate ventilation. Use only with equipment rated for cylinder pressure and cleaned for oxygen service. Cylinder temperature should not exceed 125°F (52°C). Open valve slowly. Close valve after each 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 booklets P-3499 and P-14-153. Obtain from your local supplier.

FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, qualified personnel may give oxygen. Call a physician.

RX ONLY

WARNING! Administration of 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.

Rx only IN CASE OF EMERGENCY CALL 1-800-645-4633

Copyright 1997-1998, 2003, 2005 Praxair Technology, Inc.

DO NOT REMOVE THIS LABEL MMG-3-0 (10/05)

Praxair, the flowing airstream design and Medipure are trademarks of Praxair Technology, Inc. DISTRIBUTED BY PRAXAIR, INC, DANBURY, CT 06810-5113

INGREDIENTS AND APPEARANCE

HELIUM OXYGEN MIXTURE 
helium oxygen mixture gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59579-009
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41)	HELIUM	800 mL  in 1 L
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	200 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59579-009-01	7900 L in 1 CYLINDER; Type 0: Not a Combination Product	08/01/2007
2	NDC: 59579-009-02	5975 L in 1 CYLINDER; Type 0: Not a Combination Product	08/01/2007
3	NDC: 59579-009-03	2010 L in 1 CYLINDER; Type 0: Not a Combination Product	08/01/2007
4	NDC: 59579-009-04	963 L in 1 CYLINDER; Type 0: Not a Combination Product	08/01/2007
5	NDC: 59579-009-05	595 L in 1 CYLINDER; Type 0: Not a Combination Product	08/01/2007
6	NDC: 59579-009-06	368 L in 1 CYLINDER; Type 0: Not a Combination Product	08/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA205851	08/01/2007

Labeler - Praxair Distribution, Inc. (042845636)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Distribution, Inc		161317490	manufacture(59579-009)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Distribution, Inc.		044574523	manufacture(59579-009)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Distribution, Inc.		045252439	manufacture(59579-009)