Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 67152-001-01, 67152-001-02, 67152-001-03, 67152-001-04, view more67152-001-05 - Packager: Two MP Investments, Inc. dba Respicare
- 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 28, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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PACKAGE LABEL PRINCIPAL DISPLAY PANEL
Produced by air liquefaction
OXYGEN
COMPRESSED
U.S.P. UN 1072OXYGEN 2
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.
WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION
- Use only with pressure equipment and apparatus cleaned and designed for oxygen service and rated for cylinder pressure.
- Open valve slowly. Close valve after each use and when empty. Keep cylinder, cylinder valve, all equipment that connects, free of oil and grease to avoid violent ignition.
- Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Food, Drug and Cosmetic Act.
- Pursuant to recommendation by Compressed Gas Association (CGA C-7-2000), do not expose pressurized cylinders to temperatures in excess of 125◦ F.
- DO NOT REMOVE THIS PRODUCT LABEL.
Distributed by:
Respicare Home Respiratory Care
7411 Alban Station Court,
Suite A100
Springfield, Virginia 22150
(703) 440-3600
(800) 881-9207
WARNING:
HIGH PRESSURE GAS CYLINDER
Improper filling or abuse of this cylinder, or failure to heed this warning may cause serious injury or loss of life. DO NOT ALTER OR MODIFY CYLINDER OR RELATED COMPONENTS. DO NOT OVER PRESSURIZE. Keep out of reach of children. Cylinders that have been refinished and/or exposed to elevated temperatures must be hydrostatically tested before filling. do not use caustic paint strippers. Aluminum cylinders subject to action of fire or heated to temperatures in excess of 350◦ F must be withdrawn from service and condemned. Valves and safety relief devices must be removed and replaced by trained personnel. Do not alter or change safety discs. Replace pressure relief devices only with complete assemblies supplied by the valve manufacturer. DO NOT FILL WITH OXIDIZING GASES WITHOUT PROPER CLEANING. Cylinders, valves, and assemblies must be specially cleaned for oxygen. Verify cylinder content and monthly, or more frequently if required. Store and use with adequate ventilation.
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67152-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 1 L in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67152-001-01 685 L in 1 CYLINDER 2 NDC:67152-001-02 416 L in 1 CYLINDER 3 NDC:67152-001-03 249 L in 1 CYLINDER 4 NDC:67152-001-04 165 L in 1 CYLINDER 5 NDC:67152-001-05 114 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 10/28/2010 Labeler - Two MP Investments, Inc. dba Respicare (132283925) Establishment Name Address ID/FEI Business Operations Two MP Investments, Inc. dba Respicare 132283925 manufacture