9378edcc-bcbb-4551-ba65-1908ac688c8e

SPL v12
SPL
SPL Set ID 9378edcc-bcbb-4551-ba65-1908ac688c8e
Route
respiratory (inhalation)
Published
Effective Date 2019-11-19
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oxygen (99.5 L)

Identifiers & Packaging

Marketing Status
unapproved medical gas active Since 1988-01-01

Warnings and Precautions

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 PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET.  DO NOT REMOVE THIS PRODUCT LABEL.

Description

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 PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET.  DO NOT REMOVE THIS PRODUCT LABEL.


Medication Information

Warnings and Precautions

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 PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET.  DO NOT REMOVE THIS PRODUCT LABEL.

Description

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 PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET.  DO NOT REMOVE THIS PRODUCT LABEL.

Oxygen Compressed Label

OXYGEN COMPRESSED USP UN 1072  OXYGEN - 2  MEDICAL GAS Rx ONLY.  WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  CAUTION FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.  UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON OXYGEN CONCENTRATION 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.  PRODUCED BY AIR LIQUEFACTION

41014 (R07/05)  CAS 7782-44-7

res

General Warnings and Precautions

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 PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET.  DO NOT REMOVE THIS PRODUCT LABEL.

Oxygen Refrigerated Liquid Label

REFRIGERATED LIQUID

OXYGEN,

REFRIGERATED

LIQUID



USP

UN1073

OXYGEN

2

(R-K14) 116046

DANGER:ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.

               DO NOT CHANGE OR FORCE FIT CONNECTIONS.

               MAY CAUSE OR INTENSIFY FIRE: OXIDIZER.

               CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC

                  BURNS OR INJURY.

               COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY

               EXPLODE ON IGNITION OR IMPACT.

               Do not handle until all safety precautions have been read

                 and understood.

               Keep and store away from clothing and other combustible

                   materials.

               Keep valves and fittings free from grease and oil.

               Use and store only outdoors or in a well-ventilated place.

               Wear cold insulating gloves, face shield, and eye protection.

               In case of fire: Stop leak if safe to do so.

               Use aback flow preventive device in the piping.

               Use only with equipment of compatible materials of construction

                 and rated for cylinder pressure.

               Use only with equipment cleaned for oxygen service.

DO NOTchange or force fit connections.

Avoid spills. Do not walk on or roll equipment over spills.

Close valve after each use and when empty.

Always keep container in upright position.

Read and follow the Safety DataSheet (SDS) before use.

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 its

                  effect on oxygen content 01 arterial blood, may be harmful. Do not attempt to use on patients who

                  have stopped breathing unless used in conjunction with resuscitative equipment. Keep out of reach

                  of children.

                  Federal law requires that this container be refilled with oxygen USP only by establishments

                  registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act.

FIRSTAID: IF ON SKIN:Thaw frosted parts with lukewarm water. Do not

rub affected area. Get immediate medical advice/attention.

DO NOT REMOVE THIS PRODUCT LABEL.



Premier Oxygen, LLC

2185 NE Spalding Avenue

Grants Pass, OR 97526

(888) 977•9339

res


Structured Label Content

Oxygen Compressed Label (OXYGEN COMPRESSED LABEL)

OXYGEN COMPRESSED USP UN 1072  OXYGEN - 2  MEDICAL GAS Rx ONLY.  WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  CAUTION FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.  UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON OXYGEN CONCENTRATION 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.  PRODUCED BY AIR LIQUEFACTION

41014 (R07/05)  CAS 7782-44-7

res

General Warnings and Precautions (GENERAL WARNINGS AND PRECAUTIONS)

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 PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET.  DO NOT REMOVE THIS PRODUCT LABEL.

Oxygen Refrigerated Liquid Label (OXYGEN REFRIGERATED LIQUID LABEL)

REFRIGERATED LIQUID

OXYGEN,

REFRIGERATED

LIQUID



USP

UN1073

OXYGEN

2

(R-K14) 116046

DANGER:ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.

               DO NOT CHANGE OR FORCE FIT CONNECTIONS.

               MAY CAUSE OR INTENSIFY FIRE: OXIDIZER.

               CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC

                  BURNS OR INJURY.

               COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY

               EXPLODE ON IGNITION OR IMPACT.

               Do not handle until all safety precautions have been read

                 and understood.

               Keep and store away from clothing and other combustible

                   materials.

               Keep valves and fittings free from grease and oil.

               Use and store only outdoors or in a well-ventilated place.

               Wear cold insulating gloves, face shield, and eye protection.

               In case of fire: Stop leak if safe to do so.

               Use aback flow preventive device in the piping.

               Use only with equipment of compatible materials of construction

                 and rated for cylinder pressure.

               Use only with equipment cleaned for oxygen service.

DO NOTchange or force fit connections.

Avoid spills. Do not walk on or roll equipment over spills.

Close valve after each use and when empty.

Always keep container in upright position.

Read and follow the Safety DataSheet (SDS) before use.

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 its

                  effect on oxygen content 01 arterial blood, may be harmful. Do not attempt to use on patients who

                  have stopped breathing unless used in conjunction with resuscitative equipment. Keep out of reach

                  of children.

                  Federal law requires that this container be refilled with oxygen USP only by establishments

                  registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act.

FIRSTAID: IF ON SKIN:Thaw frosted parts with lukewarm water. Do not

rub affected area. Get immediate medical advice/attention.

DO NOT REMOVE THIS PRODUCT LABEL.



Premier Oxygen, LLC

2185 NE Spalding Avenue

Grants Pass, OR 97526

(888) 977•9339

res


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