Label: CARBON DIOXIDE AIR MIX gas
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Updated December 22, 2012
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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.
MEDTECH Since 1961
Medical-Technical Gases, Inc.
20 Hall Street, Medford, MA 02155
617-395-1946 FAX 617-395-9098
INGREDIENTS AND APPEARANCE
CARBON DIOXIDE AIR MIX
carbon dioxide air mix gas
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10736-012 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbon Dioxide (UNII: 142M471B3J) (Carbon Dioxide - UNII:142M471B3J) Carbon Dioxide 10 mL in 1 L Air (UNII: K21NZZ5Y0B) (Air - UNII:K21NZZ5Y0B) Air 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10736-012-02 5974.9 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 05/29/2012 Labeler - Medical-Technical Gases, Inc. (019481373) Registrant - Medical-Technical Gases, Inc. (019481373) Establishment Name Address ID/FEI Business Operations Medical-Technical Gases, Inc. 019481373 manufacture(10736-012) Establishment Name Address ID/FEI Business Operations Linde LLC 839692303 manufacture(10736-012) Establishment Name Address ID/FEI Business Operations American Carbonation Corporation 161343264 manufacture(10736-012)