The following Structured Product Label (SPL) was submitted to the FDA by A.v. Pulmonary Care for the product Oxygen (NDC 63398-1072). 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, product warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
OXYGEN COMPRESSED U.S.P. UN 1072 OXYGEN-2
FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.
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Shoulder Label (Av Pulmonary Hp O2 Sl)
WARNING: SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE. UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER A LONG DURATION WITHOUT MONITORING 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. USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET AND SAFETY PROCEDURES RECOMMENDED BY THE SUPPLIER.
WARNING: FEDERAL LAW PROHIBITS DISPENSING THIS PRODUCT WITHOUT A PRESCRIPTION. PRODUCED BY AIR LIQUEFACTION. DO NOT REMOVE THIS PRODUCT LABEL.
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