Label: COMPRESSED GAS N.O.S.- oxygen, nitrogen, carbon dioxide gas
Contains inactivated NDC Code(s)
NDC Code(s): 10736-011-01
- Packager: Medical-Technical Gases, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated December 22, 2012
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COMPRESSED GAS, N.O.S.
______ % OXYGEN USP,
_______ % NITROGEN NF,
_______% CARBON DIOXIDE USP)
UN 1956 NON-FLAMMABLE GAS 2 33331 (07/09)
OXYGEN LESS THAN 23.5%
GASES USED TO PREPARE THIS MIXTURE MEET USP OR NF SPECIFICATIONS WHERE APPLICABLE.
Rx only: CAUTION: 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. MAY VIGOROUSLY ACCELERATE COMBUSTION. MIXTURES CONTAINING LESS THAN 19.5% OXYGEN MAY CAUSE RAPID SUFFOCATION. MIXTURES CONTAINING CARBON DIOXIDE CAN INCREASE RESPIRATIONS AND HEART RATE. Keep oil and grease away. open valve slowly. Store and use with adequate ventilation. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use a back flow preventive device in th epiping. Cylinder temperature should not exceed 52° C (125° F). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS).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
MEDTECH Since 1961
Medical-Technical Gases, Inc.
20 Hall Street, Medford, MA 02155
Tel. 800 FINE GAS FAX (781)-395-9098
INGREDIENTS AND APPEARANCE
COMPRESSED GAS N.O.S.
oxygen, nitrogen, carbon dioxide gas
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10736-011 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 19.95 mL in 1 L NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN 75.05 mL in 1 L CARBON DIOXIDE (UNII: 142M471B3J) (CARBON DIOXIDE - UNII:142M471B3J) CARBON DIOXIDE 5 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10736-011-01 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(10736-011) Establishment Name Address ID/FEI Business Operations Linde LLC 839692303 manufacture(10736-011) Establishment Name Address ID/FEI Business Operations American Carbonation Corporation 161343264 manufacture(10736-011) Establishment Name Address ID/FEI Business Operations Air Products and Chemicals 060535424 manufacture(10736-011)