Label: SOUTHERN MEDICAL OXYGEN, COMPRESSED- compressed oxygen gas
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Contains inactivated NDC Code(s)
NDC Code(s): 53199-100-10 - Packager: Michael R. Mullins II Inc. dba Southern Medical
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 26, 2019
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PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP
UN1072Southern Medical
301 George Kostas Drive
Logan, WV 25601
(304) 752-1450
Produced by Air Liquefaction.
WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION. No smoking
in the presence of oxygen or a fire may result.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 resuscitation equipmentWARNING: Keep oil and grease away. Store and use with adequate ventilation. Use only with equipment
cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.Use a back flow prevention device in the piping.
Cylinder temperature should not exceed 52C (125F).
Use in accordance with the Material Safety Data Sheet.
Do not remove this product label. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOUTHERN MEDICAL OXYGEN, COMPRESSED
compressed oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53199-100 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:53199-100-10 697 L in 1 TANK; Type 0: Not a Combination Product 01/08/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 01/08/2010 Labeler - Michael R. Mullins II Inc. dba Southern Medical (079940116) Registrant - Michael R. Mullins II Inc. dba Southern Medical (079940116) Establishment Name Address ID/FEI Business Operations Michael R. Mullins II Inc. dba Southern Medical 079940116 relabel(53199-100) Establishment Name Address ID/FEI Business Operations Praxair, Inc. 183820687 manufacture(53199-100)
