FDA Label for Helium Oxygen Mix

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Helium Oxygen Mix Product Label

The following document was submitted to the FDA by the labeler of this product Encompass Medical & Specialty Gases Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.Principal Display Panel



COMPRESSED GAS , OXIDIZING, N.O.S. (70% HELIUM USP, 30% OXYGEN USP) UN 3156
NON-FLAMMABLE GAS  2    OXIDIZER 5.1
34313 (01/09)     OXYGEN CONTENT OVER 23.5%
Rx only. CAUTION: Federal law prohibits dispensing without prescription. WARNING: Administration of this gas may be hazardous or contraindicated. For use only by or under 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. WARNING: HIGH PRESSURE OXIDIZING GAS. MAY VIGOROUSLY ACCELERATE COMBUSTION. Store and use with adequate ventilation. Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperatures should not exceed 52C (125F). Open valve slowly. Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.  HELIUM CAS: 7440-59-7   OXYGEN CAS: 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL.
Cylinders must be refilled by:
Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109
CONTENTS:  LTRS    CU. FT.


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