Label: CARBON DIOXIDE-AIR MIXTURE gas
- NDC Code(s): 46123-118-01, 46123-118-02, 46123-118-03
- Packager: Roberts Oxygen Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated November 19, 2020
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PRINCIPAL DISPLAY PANEL
COMPRESSED GAS, N.O.S.
(% AIR, USP % CARBON DIOXIDE, USP)
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 if 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. WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY INCREASE RESPIRATION AND HEARTRATE. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. Do not handle until all safety precautions have been read and understood.
Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for the cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
CAS: AIR 132259-10-0, CARBON DIOXIDE 124-38-9 DO NOT REMOVE THIS PRODUCT LABEL.
Roberts Oxygen Company, Inc.
PO Box 5507 Rockville, MD 20855
INGREDIENTS AND APPEARANCE
CARBON DIOXIDE-AIR MIXTURE
carbon dioxide-air mixture gas
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-118 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 100 mL in 1 L OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 210 mL in 1 L Inactive Ingredients Ingredient Name Strength NITROGEN (UNII: N762921K75) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46123-118-01 680 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1966 2 NDC:46123-118-02 2209 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1966 3 NDC:46123-118-03 6088 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1966 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 01/01/1966 Labeler - Roberts Oxygen Company, Inc. (042646877) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 020325953 manufacture(46123-118) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 788511095 manufacture(46123-118)