Heliox by A-OX WELDING SUPPLY CO., INC. HELIOX gas

Heliox by

Drug Labeling and Warnings

Heliox by is a Prescription medication manufactured, distributed, or labeled by A-OX WELDING SUPPLY CO., INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

PurityPlus Specialty Gases by A-OX Welding Supply

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

UN3156

PPG HEOX30K Part Number

Medical Gas Mixture

30 percent Oxygen, USP CAS: 7782-44-7

Balance Helium, USP CAS: 7440-59-7

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.

DANGER CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE OR INTENSIFY FIRE; OXIDIZER.

Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. 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. Use only with equipment cleaned for oxygen service. Open valve slowly. 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

A-OX Welding Supply Co.

101 N. Harlem Ave.

Sioux Falls, SD 57104

605.336.1125

INGREDIENTS AND APPEARANCE

HELIOX 
heliox gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10297-008
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	300 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
HELIUM (UNII: 206GF3GB41)	700 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10297-008-01	637.13 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/2018
2	NDC: 10297-008-02	5810.62 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/2018
3	NDC: 10297-008-03	7744.66 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205737	06/01/2018

Labeler - A-OX WELDING SUPPLY CO., INC. (024372385)

Establishment
Name	Address	ID/FEI	Business Operations
A-OX WELDING SUPPLY CO., INC.		024372385	manufacture(10297-008)