Label: OXYGEN gas
-
Contains inactivated NDC Code(s)
NDC Code(s): 69044-123-01 - Packager: OXYGEN UTAH
- 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 June 12, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Cylinder Label
WARNING
For Emergency use only when administered by properly trained personnel for oxygen deficiency or resuscitation. For all other medical applicatios.
RX ONLY
Uninterrupted use of high concentrations of oxygen for more than five hours may be harmful. Do not attempt to use on patients who have stopped breathing unless in conjunction with resuscitative equipment.
PRESSURE:_________PSIGat 70 F
Cylinder Size:_________
Contents:__________ Liters/Cu.Ft.
STORAGE AND HANDLING WARNING
Keep out of reach of children.CONTENTS UNDER HIGH PRESSURE AND CAN VIGOROUSLY ACCELERATE COMBUSTION. Keep free from oil or grease. Do not use or store near heat or open flame and use only with equipment condition for oxygen service.
REFILL NOTICE
Federal law requires that this container be refilled with oxygen U.S.P. only by estalishements registered as a drug producer in accordance with the Federal Food, Drug and Cosmetic Act.
OXYGEN DISPENSING DEVICE NOTICE
For medical use only with pressure regulator designed for oxygen.
WARNING: The amount of oxygen contained may be insufficient for medical use unless used with the device indicaed and for the purpose indicated in the device label.
CGA VALUE WARNING
HIGH PRESSURE OXIDIZING GAS: Open valve slowly. Close valve after each use and when empty. Use only with Pressure reducing equipment and apparatus designed and cleaned for oxygen service and related for cylinder pressure.
-
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69044-123 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 210 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69044-123-01 1 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 06/12/2014 Labeler - OXYGEN UTAH (015557586) Establishment Name Address ID/FEI Business Operations OXYGEN UTAH 015557586 manufacture(69044-123)