OXYGEN by Rochester Welding Supply Corp. OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Rochester Welding Supply Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP - OXYGEN-2

PRESSURE:_________ PSIG AT 70 F  SIZE: ______________  CONTENTS____________LITERS  RETURN WITH 25 PSIG.  UN 1072

PRODUCED BY AIR LIQUEFACTION  TO BE REFILLED BY RWS AUTHORIZED FACILITY ONLY  CAS 7782-44-7  RWSLB2 REV 01/09

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP - OXYGEN-2

PRESSURE:_________ PSIG AT 70 F  SIZE: ______________  CONTENTS____________LITERS  RETURN WITH 25 PSIG.  UN 1072

PRODUCED BY AIR LIQUEFACTION  TO BE REFILLED BY RWS AUTHORIZED FACILITY ONLY  CAS 7782-44-7 RWSLB3 REV 01/09  MADE IN THE USA

REFRIGERATED LIQUID LABEL

OXYGEN REFRIGERATED LIQUID U.S.P.  UN 1073 OXYGEN-2

GROSS WT:____ LBS. OZ. NET WT. _____________ LBS. OZ. SIZE______________ CONTENTS___________ LITERS

OXYGEN PRODUCED BY AIR LIQUEFACTION  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  DO NOT CHANGE OR FORCE FIT CONNECTIONS.  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.

FOR LIQUID WITHDRAWAL WEAR FACE SHIELD AND GLOVES.  DO NOT GET LIQUID IN EYES, ON SKIN OR CLOTHING.  DO NOT DROP.  USE HAND TRUCK SPECIFICALLY DESIGNED FOR LIQUID CYLINDER MOVEMENT.  AVOID SPILLS.  DO NOT WALK OR ROLL EQUIPMENT OVER SPILLS.  USE IN ACCORDANCE WITH RWS MSDS-G046

IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.  CAS 7782-44-7  RWSLB5 REV 01/09  OXYGEN PRODUCED BY AIR LIQUEFACTION

OXYGEN CERTIFICATE OF ANALYSIS

LOT NUMBER____ SERIAL NUMBER________ AMOUNT_____________ INS. LBS GALS LITERS CU FT

USP TESTS

TEST         ID      ODOR      ASSAY

LIMITS      OK      NONE      GREATER THAN OR EQUAL TO 99.2%

RESULTS __      _____         _______

FOR CUSTOMER USE TO DOCUMENT TESTS PERFORMED ON THIS VESSEL

METHOD OF ANALYSIS IS THE PARAMAGNETIC OXYGEN ANALYZER

MANUFACTURER __________  MODEL ________ CUSTOMER WITNESSED TESTS YES__ MO___  SUPPLIERS SIGNATURE _____________  DATE____ CUSTOMER'S SIGNATURE___________ DATE___________

LIQUID OXYGEN DELIVERY TAG  THIS VESSEL CONTAINS OXYGEN U.S.P. (SEE REVERSE SIDE FOR TEST RESULTS) OXYGEN PRODUCED BY THE AIR LIQUEFACTION PROCESS - MEDICAL GASES

MANUFACTURED BY ROCHESTER WELDING SUPPLY CORP 510 STATE STREET ROCHESTER, NY 14608 585-325-4730

PRODUCT WARNINGS AND PRECAUTIONS

KEEP ALL OIL, GREASE, AND HYDROCARBONS AWAY.  USE ONLY WITH EQUIPMENT DESIGNED AND CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  OPEN VALVE SLOWLY AND CLOSE AFTER EACH USE.  ALWAYS SECURE CYLINDER.  STORE AND USE WITH ADEQUATE VENTILATION.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 DEGREES C (125 DEGREES F)  USE IN ACCORDANCE WITH RWS MSDS-OXY.

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.

WARNING: UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION, WITHOUT MONITORING ITS EFFECT ON OXYGEN CONTENT OF ARTERIAL BLOOD, MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.

DO NOT REMOVE THIS PRODUCT LABEL.

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53828-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53828-001-01	90 L in 1 CYLINDER
2	NDC: 53828-001-02	141 L in 1 CYLINDER
3	NDC: 53828-001-03	234 L in 1 CYLINDER
4	NDC: 53828-001-04	387 L in 1 CYLINDER
5	NDC: 53828-001-05	643 L in 1 CYLINDER
6	NDC: 53828-001-06	3172 L in 1 CYLINDER
7	NDC: 53828-001-07	6400 L in 1 CYLINDER
8	NDC: 53828-001-08	155223 L in 1 DEWAR
9	NDC: 53828-001-09	8522 L in 1 CYLINDER
10	NDC: 53828-001-10	1557 L in 1 CYLINDER
11	NDC: 53828-001-11	153864 L in 1 DEWAR
12	NDC: 53828-001-12	338870 L in 1 TANK
13	NDC: 53828-001-13	387762 L in 1 TANK
14	NDC: 53828-001-14	61911 L in 1 TANK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1935

Labeler - Rochester Welding Supply Corp. (013133509)

Registrant - Rochester Welding Supply Corp. (013133509)

Establishment
Name	Address	ID/FEI	Business Operations
Rochester Welding Supply Corp.		013133509	manufacture