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Helium Oxygen Mixture Prescribing Information

Package insert / product label
Dosage form: gas

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 one

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

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 label two

HELIUM OXYGEN MIXTURE
helium oxygen mixture gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59579-009
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM800 mL in 1 L
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN200 mL in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59579-009-017900 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2007
2NDC:59579-009-025975 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2007
3NDC:59579-009-032010 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2007
4NDC:59579-009-04963 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2007
5NDC:59579-009-05595 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2007
6NDC:59579-009-06368 L in 1 CYLINDER; Type 0: Not a Combination Product08/01/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA20585108/01/2007
Labeler - Linde Gas & Equipment Inc. (042845636)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas & Equipment Inc.161317490manufacture(59579-009)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas & Equipment Inc.044574523manufacture(59579-009)
Establishment
NameAddressID/FEIBusiness Operations
Linde Gas & Equipment Inc.045252439manufacture(59579-009)