OXYGEN by Genter Healthcare, Inc OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Genter Healthcare, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED U.S.P.  UN 1072  OXYGEN-2  USE: FOR OXYGEN DEFICIENCY OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL PROPERLY INSTRUCTED IN OXYGEN ADMINISTRATION.  CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.  PRODUCED BY AIR LIQUEFACTION.

WARNING: DO NOT USE HIGH CONCENTRATIONS FOR MORE THAN 5 HOURS WITHOUT 1 HOUR INTERRUPTION.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.  KEEP CYLINDER, CYLINDER VALVE, ALL EQUIPMENT AND CONNECTIONS FREE OF OIL AND GREASE TO AVOID VIOLENT IGNITION.  DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME.  USE ONLY WITH PRESSURE REDUCING EQUIPMENT AND APPARATUS DESIGNED FOR USE WITH OXYGEN.

LOT NO. ___________  EXPIRATION DATE____________ LITERS__________ PART# A80024  MADE IN USA.

OXYGEN REFRIGERATED LIQUID LABEL

OXYGEN REFRIGERATED LIQUID USP  UN 1073  OXYGEN-2  CONTENTS______LITERS  ALWAYS 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.  AVOID SPILLS.  DO NOT WALK ON 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 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.  CAS NO 7782-44-7

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65248-001
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: 65248-001-01	248 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1993
2	NDC: 65248-001-02	426 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1993
3	NDC: 65248-001-03	671 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1993
4	NDC: 65248-001-04	3462 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1993
5	NDC: 65248-001-05	18060 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1993
6	NDC: 65248-001-06	26660 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1993
7	NDC: 65248-001-07	30960 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1993

Labeler - Genter Healthcare, Inc (884272121)

Registrant - Genter Healthcare, Inc (884272121)

Establishment
Name	Address	ID/FEI	Business Operations
Genter Healthcare, Inc		884272121	manufacture(65248-001)