Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 60980-001-01, 60980-001-02, 60980-001-03, 60980-001-04, view more60980-001-05, 60980-001-06, 60980-001-07, 60980-001-08, 60980-001-09, 60980-001-10 - Packager: Indian River Oxygen, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 19, 2018
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PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP
UN1072
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. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only be establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use.
CAS 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL.
INDIAN RIVER OXYGEN, INC.
650 ANGLE ROAD
FORT PIERCE, FL 34947
772-461-7745
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PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP
UN1072
Produced by Air Liquefaction.
CONTENTS:
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. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Keep out of reach of children.
Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act.
DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZIER.
CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.
Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. CAS: 7782-44-7
DO NOT REMOVE THIS PRODUCT LABEL.
INDIAN RIVER OXYGEN, INC.
650 ANGLE ROAD
FORT PIERCE, FL 34947
772-461-7745
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60980-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99.8 L in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60980-001-01 2265 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 2 NDC:60980-001-02 3454 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 3 NDC:60980-001-03 6909 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 4 NDC:60980-001-04 9344 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 5 NDC:60980-001-05 5097 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 6 NDC:60980-001-06 240 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 7 NDC:60980-001-07 680 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 8 NDC:60980-001-08 164 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 9 NDC:60980-001-09 255 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 10 NDC:60980-001-10 425 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205865 01/01/2003 Labeler - Indian River Oxygen, Inc. (122627206) Establishment Name Address ID/FEI Business Operations Indian River Oxygen, Inc. 122627206 manufacture(60980-001)