Oxygen
FDA Label NDC 45405-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gas Innovations Llc for the product Oxygen (NDC 45405-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding oxygen compressed usp product label, oxygen refrigerated liquid usp product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Oxygen Compressed Usp Product Label

OXYGEN,
COMPRESSED
USP

UN1072
PRODUCED BY AIR LIQUEFACTION

OXYGEN 2

18033 (12/14)

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all othe 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. Keep out of reach of children. 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 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. Incase 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. 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.
CAS 7782-44-7      DO NOT REMOVE THIS PRODUCT LABEL

ALLIED GASES
945 E CURRY RD • Tempe AZ85281
(480) 894-6000

Oxygen Refrigerated Liquid Usp Product Label

REFIGERATED LIQUID

OXYGEN,
REFIGERATED
LIQUID
USP

UN1073

OXYGEN 2

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all othe 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. Keep out of reach of children.

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.

Produced by Air Liquefaction.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS REFIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY . COMBUSTIBLS IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

Do not handle until all safety precautions have been read and understood. Keep away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Usa 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 rollequipment over spills. Close valve after each use and when empty. always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarn water. Do not rub affected area. Get immediate medical advice/attention.

CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL

ALLIED GASES
945 E CURRY RD • Tempe AZ85281
(480) 894-6000

41533
(01/15)

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