FDA Label for Carbon Dioxide Air Mix

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Carbon Dioxide Air Mix Product Label

The following document was submitted to the FDA by the labeler of this product Medical-technical Gases, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.Principal Display Panel




DO NOT REMOVE THIS LABEL
COMPRESSED GASES, N.O.S.
CARBON DIOXIDE,    %
AIR, BALANCE,    %
UN 1956    CO2, Air    NON-FLAMMABLE GAS 2
Medical Gas Mixture
Gravimetric    Analyzed    Batch Analyzed
CUATION: Federal law prohibits dispensing without a prescription.
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.
CAUTION: HIGH PRESSURE GAS. OXYGEN RICH MIXTURES CAN VIGOROUSLY ACCELERATE COMBUSTION. STORE AND USE WITH ADEQUATE VENTILATION. USE EQUIPMENT RATED FOR CYLINDER PRESSURE. OPEN VALVE SLOWLY. KEEP OIL AND GREASE AWAY AND USE EQUIPMENT CLEANED FOR OXYGEN SERVICE. CYLINDER TEMPERATURE SHOULD NOT EXCEED 125F (52C). MIXTURES CONTAINING CARBON DIOXIDE COULD CONDENSE AT LOW TEMPERATURES. CLOSE VAVLE TIGHTLY AND REPLACE CYLINDER CAP WHEN NOT IN USE AND WHEN EMPTY. USE IN ACCORDANCE WITH MED-TECH MATERIAL SAFETY DATA SHEETS.
GASES USED TO PREPARE THIS MIXTURE MEET USP SPECIFICATIONS.
ALL CONCENTRATIONS ARE EXPRESSED AS % MOL/MOL OR % VOL/VOL.
1994
MEDTECH Since 1961
Medical-Technical Gases, Inc.
20 Hall Street, Medford, MA 02155
617-395-1946    FAX 617-395-9098


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