Oxygen Helium Mixture 40/60
FDA Label NDC 10014-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aero All Gas Company for the product Oxygen Helium Mixture 40/60 (NDC 10014-007). 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 package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Package Label.Principal Display Panel

COMPRESSED GAS MIXTURE, USP        UN1956 Rx ONLY
Oxygen 40%/ Helium 60%
ALL-GAS THE AERO ALL-GAS COMPANY 3150 Main St. Hartford, CT 06120 (860) 278-AERO (2376)
ACC-24
NON-FLAMMABLE GAS 2  OXIDIZER 5.1
WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use administration of gas mixture, and is familiar with the indications, effects, dosages, methods,  and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken. CAUTION: HIGH PRESSURE GAS. MAY VIGOROUSLY ACCELERATE COMBUSTION. Store and use with adequate ventilation. Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Cylinder temperature should not exceed 52C (125F). Open valve slowly.     Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet. FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician. DO NOT REMOVE THIS PRODUCT LABEL.

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