Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 65248-001-01, 65248-001-02, 65248-001-03, 65248-001-04, view more65248-001-05, 65248-001-06, 65248-001-07 - Packager: Genter Healthcare, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated December 31, 2018
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OXYGEN COMPRESSED LABEL
OXYGEN COMPRESSED U.S.P. UN 1072 OXYGEN-2 USE: FOR OXYGEN DEFICIENCY OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL PROPERLY INSTRUCTED IN OXYGEN ADMINISTRATION. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION. PRODUCED BY AIR LIQUEFACTION.
WARNING: DO NOT USE HIGH CONCENTRATIONS FOR MORE THAN 5 HOURS WITHOUT 1 HOUR INTERRUPTION. DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT. KEEP CYLINDER, CYLINDER VALVE, ALL EQUIPMENT AND CONNECTIONS FREE OF OIL AND GREASE TO AVOID VIOLENT IGNITION. DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME. USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR USE WITH OXYGEN.
LOT NO. ___________ EXPIRATION DATE____________ LITERS__________ PART# A80024 MADE IN USA.
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OXYGEN REFRIGERATED LIQUID LABEL
OXYGEN REFRIGERATED LIQUID USP UN 1073 OXYGEN-2 CONTENTS______LITERS ALWAYS KEEP CONTAINER IN UPRIGHT POSITION. WARNING: DO NOT CHANGE OR FORCE FIT CONNECTIONS. EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT. 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 SUITABLE HAND TRUCK FOR CONTAINER MOVEMENT. AVOID SPILLS. DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS. CONTAINER TEMPERATURE SHOULD NOT EXCEED 52C (125 F) CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING. USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET (MSDS) FIRST AID: IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.
WARNING: 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. DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING, UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT. PRODUCED BY AIR LIQUEFACTION. DO NOT REMOVE THIS PRODUCT LABEL. CAS NO 7782-44-7
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65248-001 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:65248-001-01 248 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1993 2 NDC:65248-001-02 426 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1993 3 NDC:65248-001-03 671 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1993 4 NDC:65248-001-04 3462 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1993 5 NDC:65248-001-05 18060 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1993 6 NDC:65248-001-06 26660 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1993 7 NDC:65248-001-07 30960 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1993 Labeler - Genter Healthcare, Inc (884272121) Registrant - Genter Healthcare, Inc (884272121) Establishment Name Address ID/FEI Business Operations Genter Healthcare, Inc 884272121 manufacture(65248-001)