Label: AIR, COMPRESSED- oxygen gas
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Contains inactivated NDC Code(s)
NDC Code(s): 54632-003-01, 54632-003-02, 54632-003-03, 54632-003-04, view more54632-003-05 - Packager: U.S. Oxygen and Supply, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 21, 2014
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AIR, COMPRESSED
(MEDICAL AIR)
AIR, COMPRESSED UN1002 (MEDICAL AIR, USP) NON-FLAMMABLE GAS 2 37638 (02/05)
WARNING: For breathing support when used by properly trained personnel. For medical applications, Rx only.
Administration of medical air may be hazardous or contraindicated. For medical use only by or under the supervision
of a licensed practitioner who is experienced in the use and administration of medical air and is familiar with
the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards,
contraindications, and side effects and the precautions to be taken. CAUTION: HIGH PRESSURE GAS. MAY ACCELERATE COMBUSTION. Keep oil and grease away. Use equipment rated for cylinder pressure. Cylinder temperature should not exceed
52° C (125° F). Close valve after each use and when empty. Use a back flow preventive device in
the piping. Use in accordance with the Material Safety Data Sheet (MSDS).
CAS: 132259-10-0 DO NOT REMOVE THIS PRODUCT LABELUS Oxygen
3028 Abrams Arlington TX 76010 (817) 652-9000
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INGREDIENTS AND APPEARANCE
AIR, COMPRESSED
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54632-003 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 21 L in 100 L Inactive Ingredients Ingredient Name Strength NITROGEN (UNII: N762921K75) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54632-003-01 690 L in 1 CYLINDER 2 NDC:54632-003-02 3160 L in 1 CYLINDER 3 NDC:54632-003-03 3470 L in 1 CYLINDER 4 NDC:54632-003-04 6270 L in 1 CYLINDER 5 NDC:54632-003-05 8510 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206023 11/15/2012 Labeler - U.S. Oxygen and Supply, LLC (944782804) Registrant - U.S. Oxygen and Supply, LLC (944782804) Establishment Name Address ID/FEI Business Operations U.S. Oxygen and Supply, LLC 944782804 manufacture(54632-003) Establishment Name Address ID/FEI Business Operations AIRGAS USA, LLC 791526940 manufacture(54632-003)