Heliox by Metro Welding Supply Corporation HELIOX gas

Heliox by

Drug Labeling and Warnings

Heliox by is a Prescription medication manufactured, distributed, or labeled by Metro Welding Supply Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

THE PERFECT MIXTURE OF LOCAL SERVICE AND CERTIFIED QUALITY

Cryogenic Gases

PurityPlus SPECIALTY GASES

Compressed gas, n.o.s. (Helium, Oxygen)

UN1956

Medical Gas Mixture

80 % Helium, USP CAS: 7440-59-7

20 % Oxygen, USP CAS: 7782-44-7

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.

Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID: IF ACCIDENTLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.

DO NOT REMOVE THIS PRODUCT LABEL

For Medical Use Only.

Ver. 3.90

Volume: 205CF

Cryogenic Gases

12620 Southfield Fwy.

Detroit, MI, 48223

313-834-1660

INGREDIENTS AND APPEARANCE

HELIOX 
heliox gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62273-007
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	200 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
HELIUM (UNII: 206GF3GB41)	800 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62273-007-01	8495.05 L in 1 CYLINDER; Type 0: Not a Combination Product	03/28/2019
2	NDC: 62273-007-02	5663.37 L in 1 CYLINDER; Type 0: Not a Combination Product	03/28/2019
3	NDC: 62273-007-03	3539.61 L in 1 CYLINDER; Type 0: Not a Combination Product	03/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205849	03/28/2019

Labeler - Metro Welding Supply Corporation (005328869)

Establishment
Name	Address	ID/FEI	Business Operations
Metro Welding Supply Corporation		005328869	manufacture(62273-007)

Establishment
Name	Address	ID/FEI	Business Operations
Metro Welding Supply Corporation		079716147	manufacture(62273-007)