Oxygen

Oxygen
SPL v14
SPL
SPL Set ID 612ee482-2236-4641-b782-649f4969a90d
Route
NASAL
Published
Effective Date 2024-10-08
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxygen (99 L)

Identifiers & Packaging

Marketing Status
NDA Active Since 1965-01-01

Description

OXYGEN COMPRESSED USP UN 1072 OXYGEN 2 (R-K14) 115858 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 of arterial blood may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. In case of fire: Stop leak if safe to do so. Use a backflow preventive device in the piping. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52° C (125°F). Read and follow the Safety data Sheet (SDS) before use. KEEP OUT OF THE REACH OF CHILDREN. Keep valve protective cap in place when not in use. User shall secure cylinders in use and in storage. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL   Rev: 3/15


Medication Information

Description

OXYGEN COMPRESSED USP UN 1072 OXYGEN 2 (R-K14) 115858 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 of arterial blood may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. In case of fire: Stop leak if safe to do so. Use a backflow preventive device in the piping. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52° C (125°F). Read and follow the Safety data Sheet (SDS) before use. KEEP OUT OF THE REACH OF CHILDREN. Keep valve protective cap in place when not in use. User shall secure cylinders in use and in storage. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL   Rev: 3/15

Oxygen Compressed Label

OXYGEN COMPRESSED USP

UN 1072

OXYGEN 2

(R-K14) 115858

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 of arterial blood may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. In case of fire: Stop leak if safe to do so. Use a backflow preventive device in the piping. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52° C (125°F). Read and follow the Safety data Sheet (SDS) before use. KEEP OUT OF THE REACH OF CHILDREN. Keep valve protective cap in place when not in use. User shall secure cylinders in use and in storage. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL   Rev: 3/15

Oxygen Refrigerated Label

OXYGEN,

REFRIGERATED LIQUID USP

OXYGEN 2 

UN 1073

(R-K14)115859

↑ ALWAYS KEEP CONTAINER IN UPRIGHT POSITION ↑

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 of arterial blood may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. Keep out of the reach of children: and Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacture in accordance with the Federal Food, Drug, and Cosmetic Act. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED GAS: MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE OR IGNITION ON 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 a back 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 NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical attention. KEEP OUT OF REACH OF CHILDREN. User shall secure cylinders in use and storage.

CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL       Rev:3/15


Structured Label Content

Oxygen Compressed Label (OXYGEN COMPRESSED LABEL)

OXYGEN COMPRESSED USP

UN 1072

OXYGEN 2

(R-K14) 115858

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 of arterial blood may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. In case of fire: Stop leak if safe to do so. Use a backflow preventive device in the piping. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52° C (125°F). Read and follow the Safety data Sheet (SDS) before use. KEEP OUT OF THE REACH OF CHILDREN. Keep valve protective cap in place when not in use. User shall secure cylinders in use and in storage. CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL   Rev: 3/15

Oxygen Refrigerated Label (OXYGEN REFRIGERATED LABEL)

OXYGEN,

REFRIGERATED LIQUID USP

OXYGEN 2 

UN 1073

(R-K14)115859

↑ ALWAYS KEEP CONTAINER IN UPRIGHT POSITION ↑

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 of arterial blood may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. Keep out of the reach of children: and Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacture in accordance with the Federal Food, Drug, and Cosmetic Act. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED GAS: MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE OR IGNITION ON 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 a back 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 NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical attention. KEEP OUT OF REACH OF CHILDREN. User shall secure cylinders in use and storage.

CAS: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL       Rev:3/15


Advanced Ingredient Data


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