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OXYGEN

South Jersey Welding Supply
South Jersey Welding Supply


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Oxygen HP Label

OXYGEN COMPRESSED USP UN 1072  OXYGEN 2 FILLED AND SERVICED BY SOUTH JERSEYWELDING SUPPLY VINELAND, NJ

PRODUCED BY AIR LIQUEFACTION

WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. open valve slowly. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Cylinder temperature should not exceed 125 degrees F (52 degrees C). CLOSR VALVE TIGHTLY AND REPLACE CYLINDER CAP WHEN NOT IN USE AND WHEN EMPTY. Use in accordance with supplier's MATERIAL SAFETY DATA SHEET.

IN CASE OF EMERGENCY: CALL CHEMTREC 1-800-424-9300

WARNING:FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS, (Rx ONLY). Use only as directed by a licensed practitioner. 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 REMOVE THIS LABEL


OXYGEN

OXYGEN CERTIFICATE OF ANALYSIS

South Jersey Welding Supply CERTIFICATE OF ANALYSIS OXYGEN (USP) CUSTOMER This letter is to provide you with the certification you requested for Oxygen, USP, Lot# ________________ supplied to you in cylinder / 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 the 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 customer's obligation to comply with other portions of 21 CFR 210 and 211, including but not limited to 21 CFR 211.265 (finished product testing) for cylinders and vessels filled from these supply cylinders. These cylinders are not certfiied for instrument calibration purposes.

Test Requirements         USP Specification         Lot Analysis

IdentifIcation                    Pass

Odor                                Pass

Carbon Dioxide                 Less than 0.03%

Carbon Monoxide              Less than 0.001%

Assay                              Greater than 99.0%

NOTE: The USP/NF exempts facilities that manufacture Oxygen USP by the Air Liquefaction Process from the test 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 the Servomex Model 0A244D Supplier Signature __________________________ Date ___________________

EXP 00-0000

SOUTH JERSEY

SCF 0000

WELDING SUPPLY

LOT 00000000

OXYGEN

GENERAL WARNINGS AND PRECAUTIONS

DO NOT REMOVE THIS LABEL

Rx ONLY

Oxygen Refrigerated Liq Label

OXYGEN REFRIGERATED LIQUID USP UN1073  OXYGEN 2  CAS: 77-82-44-7

WARNING! EXTREMELY COLD OXIDIZING LIQUID AND GAS. VIGOROUSLY ACCELERATES COMBUSTION. CAN CAUSE SEVERE FROSTBITE. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

Do not drop. use hand truck for container movement. Keep oil and grease, and combustibles away. Keep away from heat, flame. and sparks. Use with equipment cleaned for oxygen service. Do not get liquid in eyes, on skin, or clothing. For liquid withdrawal, wear face shield or goggles, and gloves. Avoid spills. Do not walk on or roll equipment over spills. Store and use with adequate ventilation to prevent oxygen accumulation. Close valve when not in use and when empty. Container discharge must be warmed to room temperature before breathing.

FIRST AID: IN CASE OF FROSTBITE, obtain medical treatment immediately.

IN CASE OF EMERGENCY: CALL 1-800-424-9300

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 its effect on oxygen content or 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 in conjunction with resuscitative equipment.

OXYGEN BY AIR LIQUEFACTION.  DO NOT REMOVE THIS PRODUCT LABEL. FILLED BY SOUTH JERSEY WELDING SUPPLY VINELAND, NJ  PMG-9USP (10/93)

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

Lot Number _________

OXYGEN

OXYGEN

OXYGEN GAS

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:11056-001
Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Oxygen Oxygen 99 L

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11056-001-01 169 in 1 CYLINDER
2 NDC:11056-001-02 254 in 1 CYLINDER
3 NDC:11056-001-03 311 in 1 CYLINDER
4 NDC:11056-001-04 623 in 1 CYLINDER
5 NDC:11056-001-05 566 in 1 CYLINDER
6 NDC:11056-001-06 2265 in 1 CYLINDER
7 NDC:11056-001-07 3455 in 1 CYLINDER
8 NDC:11056-001-08 4361 in 1 CYLINDER
9 NDC:11056-001-09 7051 in 1 CYLINDER
10 NDC:11056-001-10 9543 in 1 CYLINDER
11 NDC:11056-001-11 127440 in 1 DEWAR
12 NDC:11056-001-12 250971 in 1 TANK
13 NDC:11056-001-13 112 in 1 CYLINDER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1962-01-01


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