The following Structured Product Label (SPL) was submitted to the FDA by Landauer Metropolitan, Inc for the product Oxygen (NDC 63289-001). 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, product warnings and precautions, liquid product warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
OXYGEN COMPRESSED USP CAS NO 7782-44-7 UN 1072 OXYGEN-2
PRODUCED BY AIR LIQUEFACTION. USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET DO NOT REMOVE THIS PRODUCT LABEL
SIZE CONTENT
M6 170 LITERS
ML6 170 LITERS
D 425 LITERS
E 680 LITERS
N 1736
Hp Ox 1 (Laudauer Hp O2)
Hp Ox 2 (Laudauer 2hp O2)
OXYGEN REFRIGERATED LIQUID USP CAS NO 7782-44-7 UN 1073 OXYGEN-2
ALWAYS KEEP CONTAINER IN UPRIGHT POSITION. DO NOT REMOVE THIS PRODUCT LABEL CONTENTS AT 70 F AND 1 ATM WHEN FULL CONTENTS___________________________
FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY. USE IN ACCORDANCE WITH INSTRUCTIONAL LITERATURE. FEDERAL LAW REQUIRES THAT THIS CONTAINER BE REFILLED WITH OXYGEN USP ONLY BY ESTABLISHMENTS REGISTERED AS A DRUG PRODUCER IN ACCORDANCE WITH THE FEDERAL FOOD DRUG AND COSMETIC ACT.
Liquid Label 1 (Laudauer Liq O2)
Liquid Label 2 (Laudauer 2liq O2)
Liquid Label 3 (Laudauer 3liq O2)
WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.
WARNING: HIGH PRESSURE OXIDIZING GAS WHICH VIGOROUSLY ACCELERATES COMBUSTION. HANDLE AND STORE WITH CARE. DO NOT DROP. DO NOT USE OR STORE NEAR HEAT OR FLAME. KEEP FREE FROM OIL AND GREASE. USE ONLY WITH EQUIPMENT DESIGNED, CLEANED, AND RATED FOR USE WITH MEDICAL HIGH PRESSURE CYLINDER OXYGEN SYSTEMS. OPEN VALVE SLOWLY. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER AN EXTENDED PERIOD OF TIME WITHOUT MONITORING ITS EFFECTS MAY BE HARMFUL. DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING, UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.
WARNING: EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE.
DO NOT GET LIQUID IN EYES, ON SKIN, OR CLOTHING. FOR LIQUID WITHDRAWAL WEAR FACE SHIELD AND GLOVES. AVOID SPILLS. DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS).
FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.
* Please review the disclaimer below.
