Carbon Dioxide Oxygen Mixture
FDA Label NDC 54776-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spec Connection International Inc for the product Carbon Dioxide Oxygen Mixture (NDC 54776-003). 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

OXYGEN 2 NON-FLAMMABLE GAS 2 Carbon dioxide and oxygen mixtures, compressed (Carbon Dioxide, Oxygen) UN1014 Medical Gas Mixture 5% Carbon Dioxide, USP CAS: 124-38-9 Balance Oxygen, USP CAS: 7782-44-7 CAUTION: Federal law prohibits dispensing without a prescription. Rx Only. WARNING: OXIDIZING HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION. CAN INCREASE RESPIRATION AND HEART RATE. Cylinder temperature should not exceed 125 degrees F (52 degrees C). Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use equipment rated for cylinde pressure. Store and use with adequate ventilation. Do not get in eyes, on skin or clothing. Close valve after each use and when empty. Open valve slowly. 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. Secure cylinder while in transportation, storage, and in use. Use in accordance with the appropriate Serial Number: 3984921 In Emergency Call: 1-800-494-9300 Lot No: 338sci12dp1 Volume 200 Exp Date: 12/11/17 Label #: RG105 December 12, 2012 Ver 2.33 For Medical Use Only. Spec Connection International Inc 37325 sr 54 Zephyrhills, FL 33542 Ph# 813-997-8950 DO NOT REMOVE THIS PRODUCT LABEL.

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