Label: HELIUM gas
49575-020-04, view more49575-020-05, 49575-020-06, 49575-020-07, 49575-020-08, 49575-020-09
- Packager: Machine & Welding Supply Company dba Arc3 Gases South
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated November 21, 2022
If you are a consumer or patient please visit this version.
PRINCIPAL DISPLAY PANEL
HELIUM, COMPRESSED MEDICAL, USP
1636 Hwy 301 South, Dunn, NC 28334
1700 Chamberlayne Ave., Richmond, VA 23222
Rx ONLY. WARNING: Administration of Helium USP 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 Helium USP 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. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. 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 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 INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
DO NOT REMOVE THIS PRODUCT LABEL.
Cylinder Type LITERS
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49575-020 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49575-020-01 5888 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2022 2 NDC:49575-020-02 2830 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2022 3 NDC:49575-020-03 96 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2022 4 NDC:49575-020-04 374 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2022 5 NDC:49575-020-05 577 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2022 6 NDC:49575-020-06 99.5 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2022 7 NDC:49575-020-07 144.4 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2022 8 NDC:49575-020-08 377 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2022 9 NDC:49575-020-09 623 L in 1 CYLINDER; Type 0: Not a Combination Product 02/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205851 02/01/2022 Labeler - Machine & Welding Supply Company dba Arc3 Gases South (065300535) Establishment Name Address ID/FEI Business Operations Machine & Welding Supply Company dba Arc3 Gases South 065300535 manufacture(49575-020) , transfill(49575-020)