Helium, Oxygen by AIRGAS USA, LLC HELIUM, OXYGEN gas

Helium, Oxygen by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

OMPRESSED GAS, OXIDIZING, N.O.S.

(60% HELIUM USP, 40% OXYGEN USP)

UN3156

NON-FLAMMABLE GAS 2 834314 (02/17) OXIDIZER 5.1

DANGER: MAY CAUSE OR INTENSIFY FIRE: OXIDIZER 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 preventative 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 52oC/125oF. Read and follow the Safety Data Sheet (SDS) before use. WARNING: Rx only. 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 I 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. CAS OXYGEN 7782-44-7 HELIUM 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL

Airgas, Healthcare

An Air Liquide company

AIRGAS USA, LLC

Radnor, PA 19087-5283

Safety Data Sheets available at www. airgas.com

INGREDIENTS AND APPEARANCE

HELIUM, OXYGEN 
helium, oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 11054-042
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41)	HELIUM	600 mL  in 1 L
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	400 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11054-042-01	300 L in 1 CYLINDER; Type 0: Not a Combination Product	10/14/1997
2	NDC: 11054-042-02	500 L in 1 CYLINDER; Type 0: Not a Combination Product	10/14/1997
3	NDC: 11054-042-03	2260 L in 1 CYLINDER; Type 0: Not a Combination Product	10/14/1997
4	NDC: 11054-042-04	4000 L in 1 CYLINDER; Type 0: Not a Combination Product	10/14/1997
5	NDC: 11054-042-05	4500 L in 1 CYLINDER; Type 0: Not a Combination Product	10/14/1997
6	NDC: 11054-042-06	3539 L in 1 CYLINDER; Type 0: Not a Combination Product	10/14/1997
7	NDC: 11054-042-07	5663 L in 1 CYLINDER; Type 0: Not a Combination Product	10/14/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA205843	10/14/1997

Labeler - AIRGAS USA, LLC (078301808)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		003324498	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		006301766	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		032547507	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		072198059	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		079214355	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		079934743	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		620137799	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		790441885	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		827455879	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		879945632	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		946304797	manufacture(11054-042)

Establishment
Name	Address	ID/FEI	Business Operations
AIRGAS USA, LLC		947401071	manufacture(11054-042)