Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 64920-0001-2, 64920-0001-3, 64920-0001-4, 64920-0001-5, view more64920-0001-6, 64920-0001-7 - Packager: Whaba Medical, Inc.
- 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 December 16, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Principal for Oxygen Product
OXYGEN
COMPRESSED
USP
UN 1072
PRODUCED BY AIR LIQUIFICATION
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.
WARNING: Federal law prohibits dispensing without prescription. 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 conjuction with resuscitative equipment.
WARNING: Keep oil and grease away. 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 IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.
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:64920-0001 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:64920-0001-2 170 L in 1 CYLINDER; Type 0: Not a Combination Product 10/30/2009 2 NDC:64920-0001-3 246 L in 1 CYLINDER; Type 0: Not a Combination Product 10/30/2009 3 NDC:64920-0001-4 415 L in 1 CYLINDER; Type 0: Not a Combination Product 10/30/2009 4 NDC:64920-0001-5 662 L in 1 CYLINDER; Type 0: Not a Combination Product 10/30/2009 5 NDC:64920-0001-6 1724 L in 1 CYLINDER; Type 0: Not a Combination Product 10/30/2009 6 NDC:64920-0001-7 680 L in 1 CYLINDER; Type 0: Not a Combination Product 10/30/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 10/30/2009 Labeler - Whaba Medical, Inc. (015228828) Establishment Name Address ID/FEI Business Operations Whaba Medical, Inc. 015228828 manufacture(64920-0001)