Label: OXYGEN gas
-
NDC Code(s):
63580-269-05,
63580-269-06,
63580-269-07,
63580-269-08, view more63580-269-09, 63580-269-10, 63580-269-11
- Packager: Coastal Med-Tech Corp.
- 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 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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.
OXYGEN,
REFRIGERATED
LIQUID USP
UN 1073
CONTENTS ________________LITERS
CAS NO: 7782-44-7
DANGER:
MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS
REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR
INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON
IGNITION OR IMPACT.
Do not handle until all safety precautions have been read and understood.
Keep and store away from clothing and other combustible materials.
Keep valves and fittings free from grease and oil. Use and store only
outdoors or in a well-ventilated place. Wear cold insulating gloves, face
shield, and eye protection. In case of fire: Stop leak if safe to do so. Use a
back flow preventive device in the piping. Use only with equipment of
compatible materials of construction and rated for cylinder pressure. Use
only with equipment cleaned for oxygen service. DO NOT change or force
fit connections. Avoid spills. Do not walk on or roll equipment over spills.
Close valve after each use and when empty. Always keep container in
upright position. Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID:
IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected
area. Get immediate medical advice/attention.
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. Do not attempt to use on patients who have
stopped breathing unless used in conjunction with resuscitative equipment.
Produced by Air Liquefaction.
-
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63580-269 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:63580-269-06 425 L in 1 CYLINDER; Type 0: Not a Combination Product 01/10/2000 2 NDC:63580-269-07 50 L in 1 DEWAR; Type 0: Not a Combination Product 01/10/2000 3 NDC:63580-269-05 164 L in 1 CYLINDER; Type 0: Not a Combination Product 01/10/2000 4 NDC:63580-269-08 680 L in 1 CYLINDER; Type 0: Not a Combination Product 01/10/2000 5 NDC:63580-269-09 7080 L in 1 CYLINDER; Type 0: Not a Combination Product 01/10/2000 6 NDC:63580-269-10 255 L in 1 CYLINDER; Type 0: Not a Combination Product 01/10/2000 7 NDC:63580-269-11 1738 L in 1 CYLINDER; Type 0: Not a Combination Product 01/10/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/10/2000 Labeler - Coastal Med-Tech Corp. (116973211) Establishment Name Address ID/FEI Business Operations Coastal Med-Tech Corp. 116973211 manufacture(63580-269) Establishment Name Address ID/FEI Business Operations Coastal Med-Tech Corp. 020033805 manufacture(63580-269)