SPL v9
SPL
SPL Set ID 239f2e15-2803-490c-bbf0-ce3c15a63705
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2010-01-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (99 L)

Identifiers & Packaging

Marketing Status
UNAPPROVED MEDICAL GAS Active Since 1976-01-01

Description

FIRST AID: FOR OXYGEN DEFICIENCY IN BREATHING PERSONS OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL INSTRUCTED IN OXYGEN ADMINISTRATION. FOR OTHER MEDICAL APPLICATIONS 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 PRODUCT LABEL. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. IN CASE OF FROSTBITE OBTAIN PROFESSIONAL MEDICAL TREATMENT IMMEDIATELY.

Warnings and Precautions

FIRST AID: FOR OXYGEN DEFICIENCY IN BREATHING PERSONS OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL INSTRUCTED IN OXYGEN ADMINISTRATION. FOR OTHER MEDICAL APPLICATIONS 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 PRODUCT LABEL. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. IN CASE OF FROSTBITE OBTAIN PROFESSIONAL MEDICAL TREATMENT IMMEDIATELY.


Medication Information

Warnings and Precautions

FIRST AID: FOR OXYGEN DEFICIENCY IN BREATHING PERSONS OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL INSTRUCTED IN OXYGEN ADMINISTRATION. FOR OTHER MEDICAL APPLICATIONS 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 PRODUCT LABEL. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. IN CASE OF FROSTBITE OBTAIN PROFESSIONAL MEDICAL TREATMENT IMMEDIATELY.

Description

FIRST AID: FOR OXYGEN DEFICIENCY IN BREATHING PERSONS OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL INSTRUCTED IN OXYGEN ADMINISTRATION. FOR OTHER MEDICAL APPLICATIONS 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 PRODUCT LABEL. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. IN CASE OF FROSTBITE OBTAIN PROFESSIONAL MEDICAL TREATMENT IMMEDIATELY.

Oxygen Refrigerated Label

OXYGEN U.S.P. REFRIGERATED LIQUID - OXYGEN UN 1073  PRODUCED BY AIR LIQUEFACTION

MARKETED BY BERNENS MEDICAL

WARNING: ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  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.  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 OR HANDLE CONTAINER ROUGHLY.  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 COMPRESSED GAS ASSOCIATION PAMPHLETS G-4, G-4.1, G-4.4, P-1, P-12, AND P-14 AND WITH MATERIAL SAFETY DATA SHEET.

253

Product Warnings and Precautions

FIRST AID: FOR OXYGEN DEFICIENCY IN BREATHING PERSONS OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL INSTRUCTED IN OXYGEN ADMINISTRATION. FOR OTHER MEDICAL APPLICATIONS 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 PRODUCT LABEL. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.

IN CASE OF FROSTBITE OBTAIN PROFESSIONAL MEDICAL TREATMENT IMMEDIATELY.


Structured Label Content

Oxygen Refrigerated Label (OXYGEN REFRIGERATED LABEL)

OXYGEN U.S.P. REFRIGERATED LIQUID - OXYGEN UN 1073  PRODUCED BY AIR LIQUEFACTION

MARKETED BY BERNENS MEDICAL

WARNING: ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  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.  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 OR HANDLE CONTAINER ROUGHLY.  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 COMPRESSED GAS ASSOCIATION PAMPHLETS G-4, G-4.1, G-4.4, P-1, P-12, AND P-14 AND WITH MATERIAL SAFETY DATA SHEET.

253

Product Warnings and Precautions (PRODUCT WARNINGS AND PRECAUTIONS)

FIRST AID: FOR OXYGEN DEFICIENCY IN BREATHING PERSONS OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL INSTRUCTED IN OXYGEN ADMINISTRATION. FOR OTHER MEDICAL APPLICATIONS 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 PRODUCT LABEL. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.

IN CASE OF FROSTBITE OBTAIN PROFESSIONAL MEDICAL TREATMENT IMMEDIATELY.


Advanced Ingredient Data


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