Oxygen Helium Mixture 30/70

Manufacturer
AGL Inhalation Therapy Co.
Effective date
2026-01-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 22:06:28

Label at a glance#

ProductOxygen Helium Mixture 30/70
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AGL Certified ISO 9001:2008 Inhalation Therapy Co. CLIFTON, NJ 07015 973-478-5100
NON-FLAMMABLE GAS 2 OXYDIZER 5.1
Compressed gas, oxidizing, n.o.s. (Oxygen, Helium) UN3156 Part # K2MOH Medical Gas Mixture 30% 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. 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 before use. FIRST AID: IF ACCIDENTALLY 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. Label # AGL-8-D-124-4 01/21/16 Ver. 3.67 Volume: 4910 Liters AGL 600 Rt. 46 W CLIFTON, N.J., 07015 helium oxygen seventy thirtyhelium oxygen seventy thirty

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17575-038-012026-01-29C16284748780-149896155-a733-586f-e063-e6dba90add90oxygen helium 30/70
17575-038-022026-01-29C16284748780-149896155-a733-586f-e063-e6dba90add90oxygen helium 30/70
17575-038-032026-01-29C16284748780-149896155-a733-586f-e063-e6dba90add90oxygen helium 30/70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17575-038-01Oxygen Helium Mixture 30/704690 L in 1 CYLINDERGAS469013
17575-038-02Oxygen Helium Mixture 30/70515 L in 1 CYLINDERGAS51513
17575-038-03Oxygen Helium Mixture 30/704910 L in 1 CYLINDERGAS491013

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17575-03817575-038-01, 17575-038-02, 17575-038-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYGENS88TT14065ACTIB
HELIUM206GF3GB41IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxygen Helium Mixture 30/70OXYGEN HELIUM MIXTURE 30/70AGL Inhalation Therapy Co.3c799e75-d974-4f9d-bd47-0ffbd05b8b982026-01-01Exact identifier
ndc (package): 17575-038-03
ndc (package): 17575-038-02
ndc (package): 17575-038-01
ndc (product): 17575-038
ndc11 (package): 17575003802
ndc11 (package): 17575003803
ndc11 (package): 17575003801
spl id: 41c36c29-c24c-b53a-e063-6294a90a180a
spl set id: 3c799e75-d974-4f9d-bd47-0ffbd05b8b98

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.