Oxygen
FDA Label NDC 65856-216

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Breathe Easy Therapeutics, Inc for the product Oxygen (NDC 65856-216). 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 label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Oxygen Compressed Label

OXYGEN COMPRESSED USP UN 1072 OXYGEN-2  CAS:7782-44-7

PRODUCED BY AIR LIQUEFACTION.  WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.  UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING ITS EFFECT ON OXYGEN CONTENT OF ARTERIAL BLOOD MAY BE HARMFUL.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR OXYGEN.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING, UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.  WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION  NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.  KEEP OIL AND GREASE AWAY.  OPEN VALVE SLOWLY.  STORE AND USE WITH ADEQUATE VENTILATION.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F)  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)  IN CASE OF CHEMICAL EMERGENCY INVOLVING THIS MATERIAL CALL CHEMTREC AT 1-800-424-9300  DO NOT REMOVE THIS PRODUCT LABEL

SIZE  CONTENTS

M6      170 LITERS

C         248 LITERS

D         415 LITERS

E         682 LITERS

H         6910 LITERS

OTHER

Hp Label (Breathe Easy Hp O2)

Hp Label (Breathe Easy Hp O2)

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