Drug Labeling and Warnings

Drug Details

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OXYGEN- oxygen gas 
McKnight Inc. dba McKnight Medical

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.

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OXYGEN REFRIGERATED LIQUID USP

OXYGEN REFRIGERATED LIQUID USP UN1073  CONTENTS_________ LITERS  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  WARNING: DO NOT CHANGE OR FORCE FIT CONNECTIONS.  EXTREMELY COLD 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.  AVOID SPILLS.  DO NOT WALK OR ROLL EQUIPMENT OVER SPILLS  CONTAINER TEMPERATURE SHOULD NOT EXCEED 52C (125 F)  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE A BACK FLOW PREVENTATIVE 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.  DO NOT REMOVE THIS PRODUCT LABEL.

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OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 58276-015
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: 58276-015-01	31 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1982
2	NDC: 58276-015-02	36 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1982
3	NDC: 58276-015-03	41 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1982
4	NDC: 58276-015-04	46 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1982

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1982

Labeler - McKnight Inc. dba McKnight Medical (064471329)

Registrant - McKnight Inc. dba McKnight Medical (064471329)

Establishment
Name	Address	ID/FEI	Business Operations
McKnight Medical		064471329	manufacture(58276-015)

Revised: 1/2020

Document Id: c8506418-a062-46ee-ac8c-ab9045682785

34391-3

Set id: f315fc0e-aa1e-4ef4-8feb-bbc3506cec2d

Version: 4

Effective Time: 20200103

 

McKnight Inc. dba McKnight Medical