OXYGEN by O2 Plus, Inc OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by O2 Plus, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OXYGEN COMPRESSED LABEL

WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  CAUTION: 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 CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.  PRODUCED BY AIR LIQUEFACTION.  DO NOT REMOVE THIS PRODUCT LABEL.  WARNING: HIGH PRESSURE 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 TEMPERATURE SHOULD NOT EXCEED 52 C (125 F)  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS)

NET CONTENTS

CYLINDER TYPE   LITERS

T                              9310

K                              6900

S                              4250

D,E,Y                        3500

Q                              2320

XL                              1970

AN-E                        625

AN-D                        360

R                              570 

CAS 7782-44-7  IN CASE OF CHEMICAL EMERGENCY PLEASE CALL INFOTRAC AT 1-800-535-5053

OXYGEN REFRIGERATED LIQUID LABEL

OXYGEN REFRIGERATED LIQUID USP UN1073 OXYGEN-2  LOT#_____ CONTENTS_____LITERS  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION  WARNING: EXTREMELY COLD OXIDIZING LIQUID AND GAS UNDER PRESSURE.  VIGOROUSLY ACCELERATES COMBUSTION  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 LIN EYES, ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL WEAR FACE SHIELD AND GLOVES.  DO NOT DROP.  USE HAND TRUCK FOR CONTAINER MOVEMENT.  AVOID SPILLS.  DO NOT WALK ON OR ROLL EQUIPMENT OVER SPILLS.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  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.  CAUTION: 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 CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.  PRODUCED BY AIR LIQUEFACTION.  DO NOT REMOVE THIS PRODUCT LABEL.

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INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64464-001
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: 64464-001-01	170 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996
2	NDC: 64464-001-02	248 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996
3	NDC: 64464-001-03	426 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996
4	NDC: 64464-001-04	671 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996
5	NDC: 64464-001-05	3465 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996
6	NDC: 64464-001-06	6896 L in 1 CYLINDER; Type 1: Convenience Kit of Co-Package	01/01/1996
7	NDC: 64464-001-07	9310 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1996
8	NDC: 64464-001-08	145300 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1996
9	NDC: 64464-001-09	172000 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1996
10	NDC: 64464-001-10	387367 L in 1 TANK; Type 0: Not a Combination Product	01/01/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1996

Labeler - O2 Plus, Inc (947932075)

Registrant - O2 Plus, Inc (947932075)

Establishment
Name	Address	ID/FEI	Business Operations
O2 Plus, Inc		947932075	manufacture(64464-001)