Label: OXYGEN-HELIUM MIXTURE gas
- NDC Code(s): 46123-512-01, 46123-512-02, 46123-512-03, 46123-512-04
- Packager: Roberts Oxygen Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 21, 2025
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PRINCIPAL DISPLAY PANEL
COMPRESSED GAS, N.O.S (% OXYGEN, USP % HELIUM, USP)
UN1956
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. 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 C (125 F).
Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ACCIDENTALLY INHALED. Remov person to fresh aid and keep comfortable for breathing. Get medical advice/attention.
CAS: OXYGEN 7782-44-7, HELIUM 7440-59-7 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
OXYGEN-HELIUM MIXTURE
oxygen-helium mixture gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-512 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 300 mL in 1 L Inactive Ingredients Ingredient Name Strength HELIUM (UNII: 206GF3GB41) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46123-512-01 376 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1996 2 NDC:46123-512-02 616 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1996 3 NDC:46123-512-03 5720 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1996 4 NDC:46123-512-04 8290 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205849 01/01/1996 Labeler - Roberts Oxygen Company, Inc. (042646877) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 791818008 manufacture(46123-512)