Oxygen Liquid
FDA Label NDC 59400-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baycare Home Care, Inc. for the product Oxygen (NDC 59400-005). 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 u.s.p., refrigerated liquid oxygen u.s.p., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Oxygen U.S.P.


Oxygen Gas Label (Img0002)

Oxygen Gas Label (Img0002)










UN1072
WARNING!
High Pressure Oxidizing Gas Vigorously Accelerates Combustion

Produced by Air Liquefaction

Warning!
For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation.

Caution: RX ONLY
For other medical applications, use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours, 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. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with pressure reducing equipment and apparatus designed for oxygen service and rated for cylinder pressure. Open valve slowly before use. Close valve after each use and when empty.

Federal law requires that this container be refilled with Gaseous Oxygen USP only by establishments registered as a Drug producer in accordance with the Federal Food, Drug and Cosmetic Act.

Refrigerated Liquid Oxygen U.S.P.

Oxygen Liquid Label (Img0001)

Oxygen Liquid Label (Img0001)











UN1073
WARNING!

High Pressure Oxidizing Liquid and Gas Under Pressure
Vigorously Accelerates Combustion
May Explode on Ignition or Impact
Can Cause Severe Frostbite

PRODUCED BY AIR LIQUEFACTION   

Caution:  RX Only
Warning!

Keep oil, grease and combustibles away. 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. Use hand truck for container movement. Avoid spills. Do not walk or roll equipment over spills. Close valve after each use and when empty.

In case of frostbite, obtain medical treatment IMMEDIATELY.

Keep out of reach of children. Contents under pressure and can vigorously accelerate combustion. Keep oil and grease away. Do not use or store near heat or open flame and use only with equipment and apparatus conditioned for oxygen service.

Use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen for more than 5 hours may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.

Federal law requires that this container be refilled with Liquid Oxygen USP only by establishments registered as a Drug Producer in accordance with the Federal Food, Drug and Cosmetic Act.

* Please review the disclaimer below.