OXYGEN

Manufacturer
Capweld Inc
Effective date
2010-01-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:09:24

Label at a glance#

ProductOXYGEN
Active ingredientOxygen
Label structure4 sections

Label contents#

Full prescribing information#

OXYGEN COMPRESSED LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXYGEN COMPRESSED USP  UN 1072


PRODUCED BY AIR LIQUEFACTION

WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION.  KEEP OIL AND GREASE AWAY.  OPEN VALVE SLOWLY.  STORE AND USE WITH ADEQUATE VENTILATION.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN SERVICE.  USE A BACK FLOW PREVENTATIVE IN THE PIPING.   CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURES SHOULD NOT EXCEED 52 C (125 F)  USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS)

OXYGEN SHOULDER LABELOXYGEN SHOULDER LABEL.

GENERAL WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Warning: for emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.  For all other medical applications Rx Only.  Uninterrupted use of high concentrations of oxygen over a long duration without monitoring oxygen content of arterial blood may be harmful.  Uninterrupted use of high concentrations of oxygen for more than 5 hours may be harmful.  Do not attempt to use on patients who have stopped breathing, unless used in conjunction with resuscitative equipment.

DO NOT REMOVE THIS PRODUCT LABEL

OXYGEN REFRIGERATED LIQUID LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXYGEN REFRIGERATED LIQUID U.S.P.  UN 1073

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

WARNING: EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION.  COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.  CAN CAUSE SEVERE FROSTBITE.  STORE AND USE WITH ADEQUATE VENTILATION.  KEEP OIL, GREASE, AND COMBUSTIBLES AWAY.  NO SMOKING IN CONTAINER AREA.  DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE.  DO NOT GET LIQUID IN EYES ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL, WEAR FACE SHIELD AND GLOVES.  DO NOT DROP  USE HAND TRUCK FOR CONTAINER MOVEMENT.  AVOID SPILLS.  DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS).

FIRST AID:  IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.

OXYGEN REFRIGERATED LIQUID LABELOXYGEN REFRIGERATED LIQUID LABEL

OXYGEN CERTIFICATE OF ANALYSIS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CUSTOMER ___________________  VENDOR / SUPPLIER ________________________  THIS LETTER IS TO PROVIDE YOU WITH THE
               CERTIFICATION YOU REQUESTED FOR OXYGEN USP LOT NUMBER _______________________ SUPPLIED TO YOU IN
               CYLINDERS / VESSELS BY OUR LOCATION
               
              
These cylinders were filled in accordance with the Standard Operating
Procedures utilized for the manufacture of Medical Gases.  By
              
following these procedures, our location ensures that products are
safely manufactured in compliance with FDA’s Current Good Manufacturing
Practices
               (cGMP) Regulations.  
              
CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST
CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84.  THIS
              
CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY WITH
OTHER PORTIONS OF 21 CFR 210 AND 211, INCLUDING BUT NOT
              
LIMITED TO 21 CFR 211.165 (FINISHED PRODUCT TESTING) FOR CYLINDERS AND
VESSELS FILLED FROM THESE SUPPLY CYLINDERS.  THESE CYLINDERS ARE
               NOT CERTIFIED FOR INSTRUMENT CALIBRATION.

TEST REQUIREMENT           USP SPECIFICATION                  LOT ANALYSIS
IDENTIFICATION                         PASS
ODOR                                        PASS
CARBON DIOXIDE                    LESS THAT 0.03%
CARBON MONOXIDE                LESS THAT 0.001%
ASSAY                                     GREATER THAN 99.0%

*
NOTE: The USP/NF exempts facilities that manufacture Oxygen USP by the
Air Liquefaction process from the tests for Carbon Dioxide and Carbon
Monoxide.  
               As our label states, the Oxygen USP being supplied is manufactured by the Air Liquefaction Process.

The methodology being used to perform the USP / NF Test for
               Assay is indicated below:   Paramagnetic Analyzer    Model # _________________________
               J 700 a1

REVISION 1.0
               CERTIFICATE OF ANALYSIS - OXYGEN USP

OXYGEN COAOXYGEN COA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312172oxygen 99 % Gas for InhalationPSN1
312172oxygen 99 % Gas for InhalationSCD1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52849-100-01OXYGEN396 L in 1 CYLINDERGAS3961
52849-100-02OXYGEN663 L in 1 CYLINDERGAS6631
52849-100-03OXYGEN2266 L in 1 CYLINDERGAS22661
52849-100-04OXYGEN3455 L in 1 CYLINDERGAS34551
52849-100-05OXYGEN6910 L in 1 CYLINDERGAS69101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52849-100OXYGEN GAS [CAPWELD INC]1Legacy NDC, 5 package rows20100719_fefe2079-2105-40e8-8ae4-4d0465675335.zip

DailyMed Socrata Ingredients#

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

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52849-10052849-100-01, 52849-100-02, 52849-100-03, 52849-100-04, 52849-100-05

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
OxygenS88TT14065ACTIB

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
bf78c990-e6cf-4601-af71-97b85aba22fffefe2079-2105-40e8-8ae4-4d04656753352010-01-01WarningsExact identifier
spl id: bf78c990-e6cf-4601-af71-97b85aba22ff
spl set id: fefe2079-2105-40e8-8ae4-4d0465675335

Reported adverse events (FAERS/openFDA)#

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