Oxygen-helium Mixture Gas
FDA Label NDC 46123-511

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Roberts Oxygen Company, Inc. for the product Oxygen-helium Mixture (NDC 46123-511). 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.

Package Label.Principal Display Panel

COMPRESSED GAS, N.O.S (% OXYGEN, USP % HELIUM, USP)
UN1956
Rx only. 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 and administration of gas mixtures, 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. DANGER: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F).
Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ACCIDENTALLY INHALED. Remov person to fresh aid and keep comfortable for breathing. Get medical advice/attention.
CAS: OXYGEN 7782-44-7, HELIUM 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL.
Roberts Oxygen Company, Inc.
PO Box 5507 Rockville, MD 20855
301-948-8100

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