Dosage Form: gas

Oxygen COMPRESSED LABEL

Oxygen COMPRESSED UN 1072 Oxygen 2

15062  (04/13)

Oxygen, + U.S.P.

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 A BACK FLOW PREVENTIVE DEVICE IN THE PIPING. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F). CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. USE IN ACCORDANCE WITH THE SPECIFIC MATERIAL SAFETY DATA SHEET (MSDS) FOR THIS PRODUCT.

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 THE EFFECT ON Oxygen CONTENT OF ARTERIAL BLOOD,  MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND SPECIFICALLY DESIGNED FOR Oxygen. DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT. KEEP OUT OF REACH OF CHILDREN.

DO NOT REMOVE THIS PRODUCT LABEL.  PRODUCED BY AIR LIQUEFACTION.

CAS 7787-44-7   RETURN WITH 25 PSIG.

PRESSURE: ______     PSIG AT 70 F MADE IN USA

BADGER WELDING SUPPLIES, INC.
101 SOUTH DICKSON STREET  MADISON WI 53703

SIZE
CONTENTS _______________  LITERS __________








Oxygen REFRIGERATED LIQUID LABEL

Oxygen REFRIGERATED LIQUID U.S.P. UN 1072  Oxygen - 2 GROSS WT ___________ LBS OZ NET WT _________________ LBS OZ SIZE__________________ CONTENTS _______________ LITERS

Oxygen PRODUCED BY AIR LIQUEFACTION  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.

KEEP OIL GREASE AND COMBUSTIBLES AWAY.  USE ONLY WITH EQUIPMENT CLEANED FOR Oxygen SERVICE.  USE ONLY WITH EQUIPMENT DESIGNATED FOR AND COMPATIBLE WITH Oxygen AND RATED FOR CYLINDER PRESSURE.  STORE AND USE WITH ADEQUATE VENTILATION.  DO NOT GET LIQUID IN EYES, ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL WEAR FACE SHIELD AND GLOVES. DO NOT DROP.  USE HAND TRUCK SPECIFICALLY DESIGNATED FOR LIQUID CYLINDER MOVEMENT.  AVOID SPILLS.  DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH BOC GASES MSDS G-102. FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR Oxygen DEFICIENCY AND RESUSCITATION. FOR ALL OTHER APPLICATIONS,
Rx ONLY

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WARNING: 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 IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.
KEEP OUT OF REACH OF CHILDREN.

IN CASE OF FROSTBITE, OBTAIN MEDICAL TREATMENT IMMEDIATELY.

TO BE REFILLED BY A BOC GASES AUTHORIZED FACILITY ONLY.

CAS 7782-44-7  AIRCO  DO NOT REMOVE THIS PRODUCT LABEL MG1644E LSP 6004E 5/98

Oxygen CERTIFICATE OF ANALYSIS

THIS LETTER IS TO PROVIDE YOU WITH THE CERTIFICATION YOU REQUESTED FOR Oxygen USP, LOT _____________ 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, OR LOCATION ENSURES THAT PRODUCTS ARE SAFELY MANUFACTURED IN COMPLIANCE WITH FDA'S CURRENT GOOD MANUFACTURING PRACTICES (cGMP) REGULATIONS AND FDA MEDICAL GAS GUIDELINES.  CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84.  THIS CERTIFICATION DOES NOT ELIMINATE CUSTOMER'S OBLIGATION TO COMPLY WITH OTHER PORTIONS OF 21 CFR 210 AND 211 INCLUDING BY NOT LIMITED TO 21 CFR 211.265 (FINISHED PRODUCT TESTING) FOR CYLINDERS AND VESSELS FILLED FROM THESE SUPPLY CYLINDERS.  THESE CYLINDERS ARE NOT CERTIFIED FOR INSTRUMENT CALIBRATION PURPOSES.

TEST / REQUIREMENT                        NF SPECIFICATION                    LOT ANALYSIS

IDENTIFICATION                                        PASS

ODOR                                                            NO APPRECIABLE ODOR
CARBON DIOXIDE                                          LESS THAN 0.03%

CARBON MONOXIDE                                LESS THAN OR EQUAL TO 0.001%

ASSAY                                                            GREATER THAN OR EQUAL TO 99.0%

THE METHODOLOGY BEING USED TO PERFORM THE USP / NF TEST FOR ASSAY IS INDICATED BELOW: _____________ PARAMAGNETIC ANALYZER MODEL #________________________  _________________________ THIS METHOD IS AN ACCEPTABLE ALTERNATIVE TO THE OFFICIAL USP ORSAT METHOD FOR Oxygen ASSAY. __________________ ORSAT  SUPPLIER SIGNATURE ____________________ DATE _______________

Oxygen 
Oxygen gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:12121-001
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxygen (Oxygen) Oxygen 99 L  in 100 L
Packaging
# Item Code Package Description
1 NDC:12121-001-01 141 L in 1 CYLINDER
2 NDC:12121-001-02 234 L in 1 CYLINDER
3 NDC:12121-001-03 387 L in 1 CYLINDER
4 NDC:12121-001-04 643 L in 1 CYLINDER
5 NDC:12121-001-05 1738 L in 1 CYLINDER
6 NDC:12121-001-06 3511 L in 1 CYLINDER
7 NDC:12121-001-07 7051 L in 1 CYLINDER
8 NDC:12121-001-09 127400 L in 1 DEWAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205767 01/01/1955
Labeler - Badger Welding Supplies, Inc (023314099)
Registrant - Badger Welding Supplies, Inc (023314099)
Establishment
Name Address ID/FEI Operations
Badger Welding Supplies, Inc 023314099 manufacture(12121-001)
Revised: 10/2014
 
Badger Welding Supplies, Inc



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