Label: OXYGEN- oxygen gas
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Contains inactivated NDC Code(s)
NDC Code(s): 50789-436-01, 50789-436-02, 50789-436-03 - Packager: Maniilaq Association
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated June 6, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
MANIILAQ HEALTH CENTER
USP 93% OXYGEN
H-01
50789-436-01 OXYGEN H CYLINDER 6900 LITEROXYGEN 93%
U.S.P.OXYGEN
2Net Contents:
Oxygen (O2): 93% ± 3%
Nitrogen (N2): 4% ± 2%
Argon (Ar): 3% ± 1.5%
Carbon Dioxide (CO2): <300 ppm
Carbon Monoxide (CO): <10 ppmWARNING: HIGH PRESSURE
OXIDIZING GAS. VIGOROUSLY
ACCELERATES COMBUSTION.Keep oil and grease away.
No smoking in cylinder area.
Open and Close valves slowly.
Secure cylinder in storage and use.
Close valve after each use and when empty.
Store and use with adequate ventalation.
Use a backflow preventative device in the piping.
Cylinder temperature should not exceed 52° C (125° F).
Use in accordance with Material Safety Data Sheet (MSDS).
Use only with equipment cleaned for oxygen service and rated for cylinder pressure.WARNING: Federal Law prohibits filling this cylinder with Oxygen USP.
This cylinder may only be filled on the CFP oxygen generator system.For emergency use only when administered by properly trained
personnel for oxygen deficiency and resuscitation. For all other
medical applications, Rx only.Uniterrupted use of high concentrations of oxygen over a long duration, without
monitoring its effect on oxygen content of arterial blood may be harmfulDo not attempt to use on patients who have stopped breathing unless used in
conjunction with resuscitative equipment.Use only with pressure reducing equipment and apparatus designed for oxygen.
Return with at least 25 PSIG pressure.DO NOT REMOVE THIS PRODUCT LABEL
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50789-436 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 930 mL in 1 L Inactive Ingredients Ingredient Name Strength Nitrogen (UNII: N762921K75) Argon (UNII: 67XQY1V3KH) Carbon Dioxide (UNII: 142M471B3J) Carbon Monoxide (UNII: 7U1EE4V452) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50789-436-01 6900 L in 1 CYLINDER 2 NDC:50789-436-02 660 L in 1 CYLINDER 3 NDC:50789-436-03 400 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/2012 Labeler - Maniilaq Association (081923526) Establishment Name Address ID/FEI Business Operations Maniilaq Association 081923526 MANUFACTURE