FDA.reportPublic FDA data

Helium-Oxygen-Nitrogen Mixture

Manufacturer
Roberts Oxygen Company, Inc.
Effective date
2009-12-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:52:45

Label at a glance#

ProductHelium-Oxygen-Nitrogen Mixture
Active ingredientHelium, Oxygen
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPRESSED GAS, OXIDIZING, N.O.S.

UN3156

( _____%  ________________,
  _____%  ________________,
  _____%  ________________)

DO NOT REMOVE THIS PRODUCT LABEL. 

NON-FLAMMABLE GAS 2

OXIDIZER

ROBERTS OXYGEN COMPANY, INC. ROCKVILLE, MD 20855 PHONE: 301-948-8100

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:  HIGH PRESSURE GAS.  VIGOROUSLY ACCELERATES COMBUSTION.  KEEP OIL AND GREASE AWAY.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  OPEN VALVE SLOWLY.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH MSDS AND CGA PAMPHLET P-1 AND P-2.


 
image of cylinder labelimage of cylinder label



FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46123-027-012021-01-26C16284748780-19d75b9d1-245d-f424-e053-dadaa90a57ceHelium-Oxygen-Nitrogen Mixture
46123-027-012020-01-31C16284748780-19d75b9d1-245d-f424-e053-dadaa90a57ceHelium-Oxygen-Nitrogen Mixture

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB411
OxygenACTIVE INGREDIENTS88TT140651
HeliumACTIVE MOIETY206GF3GB411
OxygenACTIVE MOIETYS88TT140651
NitrogenINACTIVE INGREDIENTN762921K751

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46123-02746123-027-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Helium206GF3GB41ACTIB
OxygenS88TT14065ACTIB
NitrogenN762921K75IACT

Source Document#

Source XML

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
b9d37cad-9b09-1ab9-e053-2a95a90a5f1d0257219f-6fc2-4db4-add4-5a6af3ee6bbd2021-01-26Exact identifier
spl set id: 0257219f-6fc2-4db4-add4-5a6af3ee6bbd

Reported adverse events (FAERS/openFDA)#

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