Helium Oxygen Mixture Gas
FDA Label NDC 59579-009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Linde Gas & Equipment Inc. for the product Helium Oxygen Mixture (NDC 59579-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.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

Label One (Heo2one)

Label One (Heo2one)

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

Label Two (Heo2two)

Label Two (Heo2two)

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