Label: CARBOGEN gas
- NDC Code(s): 64169-004-01, 64169-004-02
- Packager: EUGENE WELDERS SUPPLY CO
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 12, 2023
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PRINCIPAL DISPLAY PANEL
INDUSTRIAL SOURCE
Compressed gas, oxidizing, n.o.s. (Carbon Dioxide, Oxygen)
UN3156
OX USPCD5 200 Part Number
Medical Gas Mixture
5. % Carbon Dioxide, USP CAS: 124-38-9
Balance Oxygen, USP CAS: 7782-44-7
Rx only
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.
DANGER CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. MAY INCREASE RESPIRATION AND HEART RATE.
Do not handle until all safety precautions have been read and understood. Avoid breathing gas. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID: IF ACCIDENTLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
DO NOT REMOVE THIS PRODUCT LABEL
For Medical Use Only.
Ver. 23.06
Lot No.: X28423P01 – Volume: 226.6 ft3 T160866
INDUSTRIAL SOURCE
6330 SE 101st Ave
Portland, OR 97226
503-235-0168
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INGREDIENTS AND APPEARANCE
CARBOGEN
carbogen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64169-004 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 950 mL in 1 L Inactive Ingredients Ingredient Name Strength CARBON DIOXIDE (UNII: 142M471B3J) 50 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64169-004-01 5270 L in 1 CYLINDER; Type 0: Not a Combination Product 12/12/2023 2 NDC:64169-004-02 690 L in 1 CYLINDER; Type 0: Not a Combination Product 12/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205767 12/12/2023 Labeler - EUGENE WELDERS SUPPLY CO (027633486) Establishment Name Address ID/FEI Business Operations Industrial Source 801576526 manufacture(64169-004)