Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 63054-0123-1, 63054-0123-2, 63054-0123-3, 63054-0123-4, view more63054-0123-5 - Packager: Alert Respiratory Services, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated July 6, 2011
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- Official Label (Printer Friendly)
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
OXYGEN, COMPRESSED USP
UN 1072
C.A.S. No. 7782-44-7
Alert Respiratory Services Inc.
12630 Metro Parkway
Ft. Myers, FL 33912
1-800-925-3785
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 administrated 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: 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.
Cylinder temperature should not exceed 52°C (125°F).
USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.
DO NOT REMOVE THIS PRODUCT LABEL.
Label
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63054-0123 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:63054-0123-1 165 L in 1 CYLINDER 2 NDC:63054-0123-2 248 L in 1 CYLINDER 3 NDC:63054-0123-3 415 L in 1 CYLINDER 4 NDC:63054-0123-4 682 L in 1 CYLINDER 5 NDC:63054-0123-5 6900 L in 1 DEWAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved medical gas 06/17/1995 Labeler - Alert Respiratory Services, Inc. (808841522) Establishment Name Address ID/FEI Business Operations Alert Respiratory Services, Inc. 808841522 REPACK Establishment Name Address ID/FEI Business Operations Air Liquide Industrial U.S. LP 831995910 MANUFACTURE