Label: AIR 90% CARBON DIOXIDE 10% gas

  • 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 air ninety carbon dioxide ten

  • INGREDIENTS AND APPEARANCE
    AIR 90% CARBON DIOXIDE 10% 
    air 90% carbon dioxide 10% gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10297-004
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBON DIOXIDE (UNII: 142M471B3J) (CARBON DIOXIDE - UNII:142M471B3J) CARBON DIOXIDE100 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    OXYGEN (UNII: S88TT14065) 189 mL  in 1 L
    NITROGEN (UNII: N762921K75) 711 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10297-004-01680 L in 1 CYLINDER; Type 0: Not a Combination Product03/11/2015
    2NDC:10297-004-022265 L in 1 CYLINDER; Type 0: Not a Combination Product03/11/2015
    3NDC:10297-004-035663 L in 1 CYLINDER; Type 0: Not a Combination Product03/11/2015
    4NDC:10297-004-048495 L in 1 CYLINDER; Type 0: Not a Combination Product03/11/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584603/11/2015
    Labeler - A-OX WELDING SUPPLY CO., INC. (024372385)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-OX WELDING SUPPLY CO., INC.024372385manufacture(10297-004)