Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 65856-216-01, 65856-216-02, 65856-216-03, 65856-216-04 - Packager: Breathe Easy Therapeutics, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated January 1, 2010
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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
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65856-216 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65856-216-01 170 L in 1 CYLINDER 2 NDC:65856-216-02 248 L in 1 CYLINDER 3 NDC:65856-216-03 426 L in 1 CAN 4 NDC:65856-216-04 671 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1992 Labeler - Breathe Easy Therapeutics, Inc (124881751) Registrant - Breathe Easy Therapeutics, Inc (124881751) Establishment Name Address ID/FEI Business Operations Breathe Easy Therapeutics, Inc 124881751 manufacture