FDA.reportPublic FDA data

Oxygen-Helium Mixture

Manufacturer
Roberts Oxygen Company, Inc.
Effective date
2009-11-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:52:49

Label at a glance#

ProductOxygen-Helium Mixture
Active ingredientOxygen
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UN1980

RARE GASES AND OXYGEN MIXTURES

OXYGEN USP     ________%         CAS# 7782-44-7
HELIUM USP       ________%        CAS# 7440-59-7

DO NOT REMOVE THIS PRODUCT LABEL

NON-FLAMMABLE GAS 2

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

Rx ONLY. WARNING:  ADMINISTRATION OF THIS 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 THIS MIXTURE AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS CONTRAINDICATED WITH THE SIDE EFFECTS, AND THE PRECAUTIONS TO BE TAKEN.

WARNING:  MIXTURES WITH CONCENTRATIONS OF OXYGEN IN EXCESS OF 23.5% MAY VIGOROUSLY ACCELERATE COMBUSTION.  KEEP OIL AND GREASE AWAY.  USE 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
46123-011-012021-01-26C16284748780-19d75b9cf-ff92-f424-e053-dadaa90a57ceOxygen - Helium Mixture
46123-011-012020-01-31C16284748780-19d75b9cf-ff92-f424-e053-dadaa90a57ceOxygen - Helium Mixture

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OxygenACTIVE INGREDIENTS88TT140651
OxygenACTIVE MOIETYS88TT140651
HeliumINACTIVE INGREDIENT206GF3GB411

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
46123-01146123-011-01

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

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
b9d30fe3-6734-59a0-e053-2a95a90a3bd66c10fa2c-97f0-494c-8be4-e9dabc483f332021-01-26Exact identifier
spl set id: 6c10fa2c-97f0-494c-8be4-e9dabc483f33

Reported adverse events (FAERS/openFDA)#

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