Oxygen
FDA Label NDC 50789-436

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Maniilaq Association for the product Oxygen (NDC 50789-436). 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 principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Principal Display Panel

MANIILAQ HEALTH CENTER
USP 93% OXYGEN
H-01
50789-436-01 OXYGEN H CYLINDER 6900 LITER

OXYGEN 93%
U.S.P.

OXYGEN
2

Net Contents:
Oxygen (O2):  93% ± 3%
Nitrogen (N2):  4% ±  2%
Argon (Ar):  3% ± 1.5%
Carbon Dioxide (CO2):  <300 ppm
Carbon Monoxide (CO):  <10 ppm

WARNING:  HIGH PRESSURE
OXIDIZING GAS.  VIGOROUSLY
ACCELERATES COMBUSTION.

Keep oil and grease away.
No smoking in cylinder area.
Open and Close valves slowly.
Secure cylinder in storage and use.
Close valve after each use and when empty.
Store and use with adequate ventalation.
Use a backflow preventative device in the piping.
Cylinder temperature should not exceed 52° C (125° F).
Use in accordance with Material Safety Data Sheet (MSDS).
Use only with equipment cleaned for oxygen service and rated for cylinder pressure.

WARNING:  Federal Law prohibits filling this cylinder with Oxygen USP.
This cylinder may only be filled on the CFP oxygen generator system.

For emergency use only when administered by properly trained
personnel for oxygen deficiency and resuscitation.  For all other
medical applications, Rx only.

Uniterrupted 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.

Use only with pressure reducing equipment and apparatus designed for oxygen.
Return with at least 25 PSIG pressure.

DO NOT REMOVE THIS PRODUCT LABEL

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