The following Structured Product Label (SPL) was submitted to the FDA by Express Medical Inc for the product Oxygen (NDC 42809-0002). 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 UN 1072 OXYGEN U.S.P. OXYGEN-2
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. Rx ONLY. PRODUCED BY AIR LIQUEFACTION
CAS 7782-44-7 PRESSURE:_____ PSIG AT 70 F SIZE_______ CONTENTS__________LITERS
Oxygen Label (Express Med Hp O2 Sl)
WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION. KEEP OIL AND GREASE AWAY. OPEN VALVE SLOWLY. USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. USER SHALL SECURE CYLINDER IN USE AND IN STORAGE. USE IN UPRIGHT POSITION. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. KEEP VALVE PROTECTIVE CAP IN PLACE WHEN NOT IN USE IF SO EQUIPPED. USE IN ACCORDANCE WITH MSDS.
WARNING: 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. DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME. RETURN WITH 25 PSIG.
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