The following Structured Product Label (SPL) was submitted to the FDA by Holston Gases, Inc for the product Oxygen (NDC 55050-0001). 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, oxygen refrigerated liquid label, general 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 - WARNING: SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE. USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET AND SAFETY PRECAUTIONS RECOMMENDED BY THE SUPPLIER. DO NOT REMOVE THIS PRODUCT LABEL.
Oxygen Shoulder Label (Holston Hp Ox)
OXYGEN, USP REFRIGERATED LIQUID UN 1073 OXYGEN - 2
CONTENTS:________________ LOT #:___________________ EXP. DATE: ______________________ ALWAYS KEEP CONTAINER IN UPRIGHT POSITION. WARNING: EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATED COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE.
KEEP OIL GREASE AND COMBUSTIBLES AWAY. USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE. 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 ON OR ROLL EQUIPMENT OVER SPILLS. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS). FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.
DO NOT REMOVE THIS PRODUCT LABEL.
Liquid Label (Holston Liq Ox)
FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY. 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. PRODUCED BY AIR LIQUEFACTION.
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