OXYGEN- oxygen gas 
P and J Oxyfill, LLC

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 COMPRESSED LABEL

OXYGEN COMPRESSED USP  UN1072  OXYGEN-2

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.

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)  CAS 7782-44-7  DO NOT REMOVE THIS PRODUCT LABEL.
HIGH PRESSURE LABEL

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OXYGEN REFRIGERATED LIQUID LABEL

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.

LIQUID LABEL

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OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11748-010
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11748-010-01113 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
2NDC:11748-010-02170 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
3NDC:11748-010-03139 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
4NDC:11748-010-04248 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
5NDC:11748-010-051724 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
6NDC:11748-010-06255 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
7NDC:11748-010-07426 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
8NDC:11748-010-08671 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
9NDC:11748-010-093462 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
10NDC:11748-010-107981 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1988
11NDC:11748-010-1131 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1988
12NDC:11748-010-1241 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1988
13NDC:11748-010-13200 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1988
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1988
Labeler - P and J Oxyfill, LLC (118493982)
Registrant - P and J Oxyfill, LLC (118493982)
Establishment
NameAddressID/FEIBusiness Operations
P and J Oxyfill, LLC118493982manufacture(11748-010)
Establishment
NameAddressID/FEIBusiness Operations
P and J Oxyfill, LLC079612085manufacture(11748-010)

Revised: 10/2023
Document Id: 609fc23e-e040-4961-9d88-fabff54884c6
Set id: c138d360-0ea2-4388-b266-a05ee4c8fa9b
Version: 9
Effective Time: 20231031
 
P and J Oxyfill, LLC