Oxygen Gas
FDA Label NDC 57957-0007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bernens Convalescent Pharmacy, Inc for the product Oxygen (NDC 57957-0007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding oxygen refrigerated label, product warnings and precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 (Bernen Lox)

Liquid Label (Bernen Lox)

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.

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