Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 63699-001-01, 63699-001-02, 63699-001-03, 63699-001-04, view more63699-001-05, 63699-001-06 - Packager: Ablecare 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 May 12, 2014
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- Official Label (Printer Friendly)
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Principal for Oxygen Product
OXYGEN, COMPRESSED USP
UN 1072
C.A.S No. 7782-44-7
WARNING: HIGH PRESSURE, OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION.
Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation.
Use only with equipment cleaned for oxygen service and rated for cylinder pressure.
Use a back flow preventative device in the piping.
Close valve after each use and when empty. Cylinder temperatures should not exceed 52°C (125°F).
Use in accordance with Material Safety Data Sheet (MSDS).
DO NOT REMOVE THIS PRODUCT LABEL.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. 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.Produced by Air Liquefaction
OXYGEN,
REFRIGERATED LIQUID
USP
UN 1073
CONTENTS: LITERSALWAYS KEEP CONTAINER IN UPRIGHT POSITION
WARNING:
DO NOT CHANGE OR FORCE FIT CONNECTIONS
EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE
VIGOROUSLY ACCELERATES COMBUSTION
NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT
COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE
ON IGNITION OR IMPACT.
CAN CAUSE SEVERE FROSTBITE.
Keep oil, grease, and combustibles away.
Use only with equipment cleaned for oxygen service.
Store and use with adequate ventilation.
Do not get liquid in eyes, on skin or clothing.
For liquid withdrawal, wear face shield and gloves.
Do not drop. Use suitable hand truck for container movement.
Container temperatures should not exceed 52 degrees C ( 125 degrees 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).FIRST AID:
IN CASE OF FROSTBITE, obtain medical treatment immediately.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. 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.Produced by Air Liquefaction
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63699-001 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:63699-001-01 160 L in 1 CYLINDER 2 NDC:63699-001-02 410 L in 1 CYLINDER 3 NDC:63699-001-03 670 L in 1 CYLINDER 4 NDC:63699-001-04 113 L in 1 CYLINDER 5 NDC:63699-001-05 3470 L in 1 CYLINDER 6 NDC:63699-001-06 33756 L in 1 DEWAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 08/31/2012 Labeler - Ablecare Medical, Inc. (787597202) Registrant - Ablecare Medical, Inc. (787597202) Establishment Name Address ID/FEI Business Operations Ablecare Medical, Inc. 787597202 manufacture(63699-001)