Drug Labeling and Warnings

Drug Details

k">

OXYGEN- oxygen gas 
Dennis Welding Supply, Inc.

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.

----------

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP  UN 1072  OXYGEN-2  WARNING: FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER 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)

SHOULDER LABEL

OXYGEN REFRIGERATED LIQUID LABEL

OXYGEN REFRIGERATED LIQUID U.S.P.  UN 1073  CRYOGENIC LIQUID PRODUCED BY AIR LIQUEFACTION  OXYGEN-2  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.  FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION.  FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.  WARNING: CAUTION FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.  DO NOT REMOVE THIS PRODUCT LABEL  

WARNING: UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN OVER 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.  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 HAND TRUCK FOR CONTAINER MOVEMENT.  AVOID SPILLS.  DO NOT WALK OR ROLL EQUIPMENT OVER SPILLS.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET.  IN CASE OF FROSTBITE OBTAIN MEDICAL TREATMENT IMMEDIATELY.

LIQUID LABEL

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 53720-001
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: 53720-001-01170 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
2NDC: 53720-001-02248 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
3NDC: 53720-001-03426 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
4NDC: 53720-001-04671 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
5NDC: 53720-001-053235 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
6NDC: 53720-001-066900 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
7NDC: 53720-001-079815 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1964
8NDC: 53720-001-08145600 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1964
9NDC: 53720-001-09145600 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1964
10NDC: 53720-001-10172000 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1964
11NDC: 53720-001-11198200 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1964
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1964
Labeler - Dennis Welding Supply, Inc. (034051037)
Registrant - Dennis Welding Supply, Inc. (034051037)
Establishment
NameAddressID/FEIBusiness Operations
Dennis Welding Supply, Inc.034051037manufacture(53720-001)

Revised: 12/2017
 
Dennis Welding Supply, Inc.


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.