Oxygen Gas
FDA Label NDC 48273-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Keen Compressed Gas Co. Inc. for the product Oxygen (NDC 48273-001). 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 label, oxygen refrigerated liquid usp label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Oxygen Compressed Usp Label

KEEN

OXYGEN, COMPRESSED USP UN 1072

DO NOT REMOVE THIS PRODUCT LABEL.

16300    12/14 MADE IN USA

OXYGEN 2

USP

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. 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 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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only by establishments registered as drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act CAS 7782-44-7Produced by Air Liquefaction

FILLED & DISTRIBUTED BY:

KEEN COMPRESSED GAS CO.

4063 NEW CASTLE AVE

NEW CASTEL, DE 19720 • (302) 594-4545

Pressure:                             PSIG at 70 OF

Size

Contents                             liters

Oxygen Refrigerated Liquid Usp Label

KEEN

FILLED & DISTRIBUTED BY:

KEEN COMPRESSED GAS CO.

4063 NEW CASTLE AVE.

NEW CASTLE, DE 19720 • (302) 594-4545

OXYGEN, REFRIGERATED LIQUID USP UN1073

OXYGEN, *U.S.P.

OXYGEN 2

Gross Wt.                            lbs.                         oz.

Net Wt.                                lbs.                         oz.

Size

                                                Contents                             Liters

*Oxygen produced by Air Liquefaction

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDER, CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBELS 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 a backflow preventive device in the piping. Use only the equipment of compatible materials 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. Always keep container in upright position. Read and follow the Safety Data Sheet (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 of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction of 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.

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

DO NOT REMOVE THIS PRODUCT LABEL

CAS: 7782-44-7                  46301   12/14

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