OXYGEN- oxygen gas 
Bernens Convalescent Pharmacy, 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.

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PRODUCT WARNINGS AND PRECAUTIONS

FIRST AID: FOR OXYGEN DEFICIENCY IN BREATHING PERSONS OR EMERGENCY RESUSCITATION WHEN USED BY PERSONNEL INSTRUCTED IN OXYGEN ADMINISTRATION. FOR OTHER MEDICAL APPLICATIONS USE ONLY AS DIRECTED BY A LICENSED PRACTITIONER. 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 REMOVE THIS PRODUCT LABEL. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.

IN CASE OF FROSTBITE OBTAIN PROFESSIONAL MEDICAL TREATMENT IMMEDIATELY.

OXYGEN REFRIGERATED LABEL

OXYGEN U.S.P. REFRIGERATED LIQUID - OXYGEN UN 1073  PRODUCED BY AIR LIQUEFACTION

MARKETED BY BERNENS MEDICAL

WARNING: ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  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 IN EYES, ON SKIN, OR CLOTHING.  FOR LIQUID WITHDRAWAL WEAR FACE SHIELD AND GLOVES.  DO NOT DROP OR HANDLE CONTAINER ROUGHLY.  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 COMPRESSED GAS ASSOCIATION PAMPHLETS G-4, G-4.1, G-4.4, P-1, P-12, AND P-14 AND WITH MATERIAL SAFETY DATA SHEET.

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LIQUID LABEL

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57957-0007
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:57957-0007-125 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1976
2NDC:57957-0007-237 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1976
3NDC:57957-0007-3400 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1976
4NDC:57957-0007-4630 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1976
5NDC:57957-0007-56900 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1976
6NDC:57957-0007-622800 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1976
7NDC:57957-0007-728800 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1976
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1976
Labeler - Bernens Convalescent Pharmacy, Inc (041603101)
Registrant - Bernens Convalescent Pharmacy, Inc (041603101)
Establishment
NameAddressID/FEIBusiness Operations
Bernens Convalescent Pharmacy, Inc041603101manufacture(57957-0007)

Revised: 12/2023
Document Id: 8d33aa23-9eeb-4bfe-aedb-515f62bddfb1
Set id: 239f2e15-2803-490c-bbf0-ce3c15a63705
Version: 6
Effective Time: 20231222
 
Bernens Convalescent Pharmacy, Inc