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 Medical-technical Gases, Inc., Medtech Gases Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HELIUM OXYGEN MIXTURE 
helium oxygen mixture gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10736-013
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: 10736-013-01	620 L in 1 CYLINDER
2	NDC: 10736-013-02	5703 L in 1 CYLINDER
3	NDC: 10736-013-03	7744 L in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		05/01/2014

Labeler - Medical-technical Gases, Inc. (019481373)

Establishment
Name	Address	ID/FEI	Business Operations
Medtech Gases Inc		066397297	manufacture(10736-013)