Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 63289-001-01, 63289-001-02, 63289-001-03, 63289-001-04, view more63289-001-05, 63289-001-06, 63289-001-07, 63289-001-08, 63289-001-09, 63289-001-10, 63289-001-11, 63289-001-12, 63289-001-13 - Packager: Landauer Metropolitan, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 1, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OXYGEN COMPRESSED LABEL
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OXYGEN REFRIGERATED LIQUID
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.
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PRODUCT WARNINGS AND PRECAUTIONS
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.
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LIQUID PRODUCT WARNINGS AND PRECAUTIONS
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.
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63289-001 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:63289-001-01 170 L in 1 CYLINDER 2 NDC:63289-001-02 248 L in 1 CYLINDER 3 NDC:63289-001-03 120 L in 1 CYLINDER 4 NDC:63289-001-04 400 L in 1 CYLINDER 5 NDC:63289-001-05 670 L in 1 CYLINDER 6 NDC:63289-001-06 900 L in 1 CYLINDER 7 NDC:63289-001-07 3400 L in 1 CYLINDER 8 NDC:63289-001-08 6800 L in 1 CYLINDER 9 NDC:63289-001-09 8400 L in 1 CYLINDER 10 NDC:63289-001-10 21 L in 1 DEWAR 11 NDC:63289-001-11 31 L in 1 DEWAR 12 NDC:63289-001-12 40 L in 1 DEWAR 13 NDC:63289-001-13 45 L in 1 DEWAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1984 Labeler - Landauer Metropolitan, Inc (121561559) Registrant - Landauer Metropolitan, Inc (121561559) Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 022933686 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 831777177 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 022150505 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 095370565 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 841338358 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 022933912 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 961574535 manufacture Establishment Name Address ID/FEI Business Operations Miller Medical & Respiratory, Inc 014761969 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply New York LLC 825888139 manufacture Establishment Name Address ID/FEI Business Operations Denmarks LLC 003468234 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 791285047 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 626129639 manufacture Establishment Name Address ID/FEI Business Operations American Home Care Supply Midatlantic LLC 832743723 manufacture Establishment Name Address ID/FEI Business Operations Genox Homecare LLC 961576548 manufacture Establishment Name Address ID/FEI Business Operations Genox Homecare LLC 004119488 manufacture Establishment Name Address ID/FEI Business Operations Genox Homecare LLC 049163454 manufacture Establishment Name Address ID/FEI Business Operations Landauer Metropolitan, Inc 121561559 manufacture Establishment Name Address ID/FEI Business Operations Landauer Metropolitan, Inc 107641649 manufacture Establishment Name Address ID/FEI Business Operations Denmarks LLC 627341670 manufacture
