Label: AIR 90% CARBON DIOXIDE 10% gas
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Contains inactivated NDC Code(s)
NDC Code(s): 10297-004-01, 10297-004-02, 10297-004-03, 10297-004-04 - Packager: A-OX WELDING SUPPLY CO., INC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 5, 2021
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PRINCIPAL DISPLAY PANEL
Purity Plus Specialty Gases by A-OX Welding Supply NON-FLAMMABLE GAS 2 Compressed gas, n.o.s. (Carbon Dioxide, Air) UN1956 PPG AIRCD10USPK
Medical Gas Mixture 10% Carbon Dioxide, USP CAS: 124-38-9 Balance Air, USP CAS: N/A
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 DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY INCREASE RESPIRATION AND HEART RATE.
Do not handle until all safety precautions have been read and understood. Avoid breathing gas. 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. Close valve after each use and when empty. Protect from sunlight when 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.
Lot No: XXX Tag No: XXX DO NOT REMOVE THIS PRODUCT LABEL For Medical Use Only. Ver. 3.76 Volume: 218.6 SCF A-OX Welding Co. 101 N Harlem Ave. Sioux Falls, SD 57104 605.336.1125
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INGREDIENTS AND APPEARANCE
AIR 90% CARBON DIOXIDE 10%
air 90% carbon dioxide 10% gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10297-004 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 Inactive Ingredients Ingredient Name Strength OXYGEN (UNII: S88TT14065) 189 mL in 1 L NITROGEN (UNII: N762921K75) 711 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10297-004-01 680 L in 1 CYLINDER; Type 0: Not a Combination Product 03/11/2015 2 NDC:10297-004-02 2265 L in 1 CYLINDER; Type 0: Not a Combination Product 03/11/2015 3 NDC:10297-004-03 5663 L in 1 CYLINDER; Type 0: Not a Combination Product 03/11/2015 4 NDC:10297-004-04 8495 L in 1 CYLINDER; Type 0: Not a Combination Product 03/11/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205846 03/11/2015 Labeler - A-OX WELDING SUPPLY CO., INC. (024372385) Establishment Name Address ID/FEI Business Operations A-OX WELDING SUPPLY CO., INC. 024372385 manufacture(10297-004)