FDA Label for Helium Oxygen Mixture
View Indications, Usage & Precautions
Helium Oxygen Mixture Product Label
The following document was submitted to the FDA by the labeler of this product Medical-technical Gases, Inc.. 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, N.O.S.
(80% HELIUM, USP, 20% OXYGEN, USP)
UN 1956
NON-FLAMMABLE GAS 2
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.
WARNING: CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED. MIXTURES CONTAINING LESS THAN 19.5% OXYGEN MAY CAUSE RAPID SUFFOCATION.
Keep oil and grease away. Close valve after each use and when empty. Do not handle until all safety precautions have been read and understood. Open valve slowly. Protect from sunlight when ambient temperature exceeds 52 degrees C/125 degrees F. Store and use in a well ventilated place. Use a back flow preventive device in the piping. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. FIRST AID: IF ACCIDENTLY INHALED: If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for breathing. Call a physician. DO NOT REMOVE THIS PRODUCT LABEL.
Medical-Technical Gases, Inc.
8 Executive Park Drive
North Billerica, MA
Tel 800 FINE GAS
Fax (781) 395-9098
www.medtechgases.com
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