Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 42411-010-01, 42411-010-02, 42411-010-03, 42411-010-04, view more42411-010-08, 42411-010-12, 42411-010-13, 42411-010-20, 42411-010-21, 42411-010-22, 42411-010-23, 42411-010-25, 42411-010-26 - Packager: Air Liquide America Specialty Gases LLC
- 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 October 5, 2010
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OXYGEN USP COMPRESSED
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WARNING: DO NOT HANDLE CYLINDER OR USE CONTENTS UNTIL: 1) YOU HAVE READ AND UNDERSTAND THE MATERIAL SAFETY DATA SHEET FOR THIS PRODUCT. CALL 1-800-231-1366 FOR MORE COPIES. 2) YOU ARE TRAINED TO USE CYLINDER AND CONTENTS, INCLUDING EMERGENCY PROCEDURES.
WARNING: HIGH PRESSURE, OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. Secure cylinder and provide adequate ventilation in storage and use. Keep oil and grease away. No smoking in cylinder area. Do not use or store near heat or open flame. Keep out of reach of children. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Cylinder temperatures should not exceed 125°F (52°C). Open valve slowly. Close valve after each use and when empty. Return with at least 25 PSIG pressure. Use in accordance with Material Safety Data Sheet.
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.
CAUTION: Federal law prohibits dispensing without prescription. 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. Produced by Air Liquefaction.
CAUTION: USE NO OIL ON VALVE OR CONNECTIONS. TRANSFILLING OF THIS GAS IS PROHIBITED.
DO NOT REMOVE THIS PRODUCT LABEL. -
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42411-010 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:42411-010-03 425 L in 1 CYLINDER 2 NDC:42411-010-01 198 L in 1 CYLINDER 3 NDC:42411-010-02 255 L in 1 CYLINDER 4 NDC:42411-010-04 708 L in 1 CYLINDER 5 NDC:42411-010-08 1558 L in 1 CYLINDER 6 NDC:42411-010-12 3540 L in 1 CYLINDER 7 NDC:42411-010-13 4390 L in 1 CYLINDER 8 NDC:42411-010-20 6514 L in 1 CYLINDER 9 NDC:42411-010-21 7108 L in 1 CYLINDER 10 NDC:42411-010-22 37212 L in 1 CYLINDER 11 NDC:42411-010-23 42650 L in 1 CYLINDER 12 NDC:42411-010-25 8609 L in 1 CYLINDER 13 NDC:42411-010-26 9544 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1960 Labeler - Air Liquide America Specialty Gases LLC (808434711) Establishment Name Address ID/FEI Business Operations Air Liquide America Specialty Gases LLC 104147434 manufacture Establishment Name Address ID/FEI Business Operations Air Liquide America Specialty Gases LLC 146549886 manufacture Establishment Name Address ID/FEI Business Operations Air Liquide America Specialty Gases LLC 802802587 manufacture Establishment Name Address ID/FEI Business Operations Air Liquide America Specialty Gases LLC 079354007 manufacture Establishment Name Address ID/FEI Business Operations Air Liquide America Specialty Gases LLC 103748765 manufacture Establishment Name Address ID/FEI Business Operations Air Liquide America Specialty Gases LLC 803778844 manufacture Establishment Name Address ID/FEI Business Operations Air Liquide America Specialty Gases LLC 134382332 manufacture Establishment Name Address ID/FEI Business Operations Air Liquide America Specialty Gases LLC 049087562 manufacture