Oxygen
FDA Label NDC 63080-679

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galloping Hill Surgical Corp. Dba Allcare Medical for the product Oxygen (NDC 63080-679). 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 compressed 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 Compressed Label

OXYGEN COMPRESSED UN 1072 OXYGEN-2  DO NOT REMOVE THIS PRODUCT LABEL.

OXYGEN U.S.P.  PRESSURE __________PSIG AT 70 F

SIZE_________  CONTENTS________________ LITERS

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 A PRESCRIPTION.  Rx ONLY.

PRODUCED BY AIR LIQUEFACTION  CAS 7782-44-7  RETURN WITH 25 PSIG.

Shoulder Label (Allcare Hp O2)

Shoulder Label (Allcare Hp O2)

Product Warnings And Precautions

WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION.  KEEP OIL AND GREASE AWAY.  OPEN VALVE SLOWLY.  USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  USER SHALL SECURE CYLINDER IN USE AND IN STORAGE.  USE IN UPRIGHT POSITION.  CLOSE VALVE AFTER EACH USE.  KEEP VALVE PROTECTIVE CAP IN PLACE WHEN NOT IN USE, IF SO EQUIPPED.  USE IN ACCORDANCE WITH MSDS.

WARNING: UNINTERRUPTED USE OF HIGH CONCENTRATIONS OF OXYGEN FOR MORE THAN 5 HOURS MAY BE HARMFUL.  DO NOT ATTEMPT TO USE ON PATIENTS WHO HAVE STOPPED BREATHING UNLESS USED IN CONJUNCTION WITH RESUSCITATIVE EQUIPMENT.  KEEP OUT OF REACH OF CHILDREN.  DO NOT USE OR STORE NEAR HEAT OR OPEN FLAME.

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