CARBON DIOXIDE OXYGEN MIXTURE gas

Carbon Dioxide Oxygen Mixture by

Drug Labeling and Warnings

Carbon Dioxide Oxygen Mixture by is a Prescription medication manufactured, distributed, or labeled by Spec Connection International Inc, Spec Connection Internation, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

CARBON DIOXIDE OXYGEN MIXTURE 
carbon dioxide oxygen mixture gas

Product 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)