Helium/Oxygen Mix by NEXAIR, LLC HELIUM/OXYGEN MIX gas

Helium/Oxygen Mix by

Drug Labeling and Warnings

Helium/Oxygen Mix by is a Prescription medication manufactured, distributed, or labeled by NEXAIR, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

COMPRESSED GAS, N.O.S. (OXYGEN HELIUM) UN1956 20% OXYGEN USP 80% HELIUM USP MIXTURE
CAS: (7782-44-7) (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.
WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.
Do not handle until all safety precautions have been read and understood. Avoid breathing gas. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for cylinder pressure. Close valve after each use and when empty. when Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet.
FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
NET CONTENTS Cylinder Size Cubic Feet Liters (Gaseous) K 200.4 5675 E 22.0 625 D-puritan 13.5 382
DO NOT REMOVE THIS PRODUCT LABEL
Distributed by nexAir nexAir, LLC . www.nexAir.com
1385 Corporate Ave. . Memphis, TN 38132 . 888-639-2474

PRINCIPAL DISPLAY PANEL

COMPRESSED GASES, OXIDIZING, N.O.S. (OXYGEN, CARBON DIOXIDE) UN3156
NON-FLAMMABLE GAS 2 OXIDIZER 5.1 Rx only
USP % OXYGEN, USP % HELIUM USP MIXTURE CAS: (7782-44-7) (7440-59-7)
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: MAY CAUSE OR INTENSIFY FIRE; OXYDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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 Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use.
NET CONTENTS Contains Cubic Feet at 70 degrees F and PSIG
DO NOT REMOVE THIS PRODUCT LABEL
Net Contents Cubic Feet: Liters:
nexAir
Distributed by nexAir, LLC . www.nexAir.com
1385 Corporate Ave. . Memphis, TN 38132 . 888-639-2474

INGREDIENTS AND APPEARANCE

HELIUM/OXYGEN MIX 
helium/oxygen mix gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 12213-801
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: 12213-801-13	382 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
2	NDC: 12213-801-28	561 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
3	NDC: 12213-801-12	5663 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205849	06/01/1996

Labeler - NEXAIR, LLC (927024422)

Establishment
Name	Address	ID/FEI	Business Operations
NEXAIR, LLC		927024422	manufacture(12213-801)