Label: HELIOX gas
- NDC Code(s): 10297-080-01, 10297-080-02, 10297-080-03
- 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 17, 2023
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PRINCIPAL DISPLAY PANEL
PurityPlus Specialty Gases by A-OX Welding Supply
Compressed gas, n.o.s. (Oxygen, Helium)
UN1956
PPG HEOX20K Part Number
Medical Gas Mixture
20 Percent Oxygen, USP CAS: 7782-44-7
Balance Helium, USP CAS: 7440-59-7
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.
WARNING CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.
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 of compatible materials of construction and rated for cylinder pressure. 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. 3.90
A-OX Welding Supply Co.
101 N. Harlem Ave.
Sioux Falls, SD 57104
605.336.1125
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INGREDIENTS AND APPEARANCE
HELIOX
heliox gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10297-080 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 200 mL in 1 L Inactive Ingredients Ingredient Name Strength HELIUM (UNII: 206GF3GB41) 800 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10297-080-01 637.13 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/2018 2 NDC:10297-080-02 5810.62 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/2018 3 NDC:10297-080-03 7744.66 L in 1 CYLINDER; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205767 06/01/2018 Labeler - A-OX WELDING SUPPLY CO., INC. (024372385) Establishment Name Address ID/FEI Business Operations A-OX WELDING SUPPLY CO., INC. 024372385 manufacture(10297-080)