Label: CARBON DIOXIDE OXYGEN MIXTURE gas
- NDC Code(s): 54776-004-01, 54776-004-02
- Packager: Spec Connection International Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 18, 2023
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PRINCIPAL DISPLAY PANEL
OXYGEN 2 NON-FLAMMABLE 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. Keep oil and grease away. Cylinder temperature should not exceed 125F (52C). Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use equipment rated for cylinder 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. SPEC CONNECTION INTERNALTIONAL, INC. 37325 STATE ROAD 54. ZEPHYRHILLS, FL 33542 813-997-7646 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:54776-004 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 800 mL in 1 L Inactive Ingredients Ingredient Name Strength CARBON DIOXIDE (UNII: 142M471B3J) 200 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54776-004-01 707 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2013 2 NDC:54776-004-02 5663 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205889 01/01/2013 Labeler - Spec Connection International Inc (059854468) Establishment Name Address ID/FEI Business Operations Spec Connection Internation, Inc. 026151816 manufacture(54776-004)