Label: CARBON DIOXIDE gas
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Contains inactivated NDC Code(s)
NDC Code(s): 46123-005-01, 46123-005-02, 46123-005-03, 46123-005-04, view more46123-005-05, 46123-005-06 - Packager: Roberts Oxygen Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 19, 2020
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PRINCIPAL DISPLAY PANEL
CARBON
DIOXIDE
USP
UN1013
NON-FLAMMABLE GAS 2
Rx ONLY. WARNING: Administration of Carbon Dioxide USP 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 Carbon Dioxide USP and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and the hazards, contraindications and side effects and the precautions to be taken. WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY CAUSE FROSTBITE. MAY INCREASE RESPIRATION AND HEART RATE. Do not handle until all safety precautions have been read and understood. Do not get in eyes, on skin, or on clothing. Use and store only outdoors or in a well-ventilated place. Use a back flow preventative device in the piping. Use only with equipment rated for cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52ºC (125ºF). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.
CAS: 124-38-9 DO NOT REMOVE THIS PRODUCT LABEL
Roberts Oxygen Company, Inc.
PO BOX 5507 Rockville, MD 20855
301-948-8100
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INGREDIENTS AND APPEARANCE
CARBON DIOXIDE
carbon dioxide gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-005 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 990 g in 1 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46123-005-01 1.13 kg in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 2 NDC:46123-005-02 1.81 kg in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 3 NDC:46123-005-03 2.95 kg in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 4 NDC:46123-005-04 9.07 kg in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 5 NDC:46123-005-05 22.68 kg in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 6 NDC:46123-005-06 34.02 kg in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205764 01/01/1967 Labeler - Roberts Oxygen Company, Inc. (042646877) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 791818008 manufacture(46123-005)