Label: HELIUM/OXYGEN MIXTURE 80/20 gas
- NDC Code(s): 21220-155-01, 21220-155-02
- Packager: General Air Service & Supply Co.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 18, 2023
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PRINCIPAL DISPLAY PANEL
COMPRESSED GAS, N.O.S. (80% HELIUM USP, 20% OXYGEN USP)
UN1956
NON-FLAMMABLE GAS 2
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 hazards, contraindications and side effects, and the precautions to be taken. DANGER: 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 value 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 ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing/ Get medical advice/attention. CAS HELIUM 7440-59-7 OXYGEN 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL
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INGREDIENTS AND APPEARANCE
HELIUM/OXYGEN MIXTURE 80/20
helium/oxygen mixture 80/20 gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21220-155 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:21220-155-01 7108 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1975 2 NDC:21220-155-02 708 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1975 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 01/01/1975 Labeler - General Air Service & Supply Co. (051227338) Establishment Name Address ID/FEI Business Operations General Air Service & Suppy Co. 006686091 manufacture(21220-155)