Label: CARBON DIOXIDE OXYGEN MIXTURE gas
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Contains inactivated NDC Code(s)
NDC Code(s): 54776-003-01, 54776-003-02 - Packager: Spec Connection International Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated December 29, 2012
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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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INGREDIENTS AND APPEARANCE
CARBON DIOXIDE OXYGEN MIXTURE
carbon dioxide oxygen mixture gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54776-003 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 200 mL in 1 L Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen 800 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54776-003-01 707 L in 1 CYLINDER 2 NDC:54776-003-02 5663 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/2013 Labeler - Spec Connection International Inc (059854468) Establishment Name Address ID/FEI Business Operations Spec Connection International, Inc. 026151816 manufacture(54776-003)