Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 64540-011-01, 64540-011-02 - Packager: Austin Respiratory Equipment,inc
- This is a repackaged label.
- Source NDC Code(s): 11390-001
- 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 November 13, 2017
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
OXYGEN,
REFRIGERATED LIQUID
USP
UN: 1073
CAS NO:7782-44-7
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WARNING
EXTREMELY COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE.
VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN
CONTACT WITYH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR
IMPACT. CAN CAUSE SEVERE FROSTBITE.
For emergency use only when administered by properly trained personnel for
Oxygen deficiency and resuscitation. For all other medical applications Rx only
Federal law prohibits dispensing without a prescription. WARNING: 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. Federal law requires that this Container be Refilled with oxygen U.S.P.
only by Establishments Registered as Drug Producer in accordance with the Federal
Food, Drug and Cosmetic Act.
KEEP OUT OF REACH OF CHILDERN.
DO NOT REMOVE THIS PRODUCT LABEL.
Produced by Air Liquefaction.
Directions for use:↑Always keep container in upright position↑. Do not change or force fit connections. Keep oil, grease, and combustibles away. No smoking in cylinder area. use only with equipment cleaned for oxygen service. Store and use with adequate ventilation. Do not get liquid in eyes, on skin, or on clothing. For liquid withdrawal, wear face shield and gloves. Do not drop. Use suitable hand truck for container movement.
Avoid spills. Do not walk or roll equipment over spills. 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 Safety data Sheet. (SDS).
FIRST AID: in case of Frostbite: obtain medical treatment immediately.
SIZE CONTENT
21 16,750 LITERS
31 24,950 LITERS
41 33,500 LITERS
AUSTIN RESPIRATORY EQUIPMENT, INC.
1676 N. Belcher Road
Clearwater, FL. 33765
(727) 467-0606
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64540-011(NDC:11390-001) Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64540-011-01 21 L in 1 DEWAR; Type 1: Convenience Kit of Co-Package 07/11/2011 2 NDC:64540-011-02 41 L in 1 DEWAR; Type 1: Convenience Kit of Co-Package 07/11/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 07/11/2011 Labeler - Austin Respiratory Equipment,inc (849265483) Registrant - Austin Respiratory Equipment,inc (849265483) Establishment Name Address ID/FEI Business Operations Austin Respiratory Equipment,inc 849265483 relabel(64540-011)