Label: HELIUM gas
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NDC Code(s):
84120-001-01,
84120-001-02,
84120-001-03,
84120-001-04, view more84120-001-05, 84120-001-06, 84120-001-07, 84120-001-08, 84120-001-09, 84120-001-10, 84120-001-11
- Packager: WSM SUPPLIER LLC.
- This is a repackaged label.
- Source NDC Code(s): 11054-004
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 3, 2024
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- Official Label (Printer Friendly)
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PRINCIPAL DISPLAY PANEL
HELIUM, COMPRESSED USP
UN1046
Rx only. WARNING: Administration of Helium 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 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. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. 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. CAS HELIUM 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL.
WSM SUPPLIER LLC
3535 NW 60th Street
Miami FL 33142 (305) 455 1220
www.wsmsupplier.com
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INGREDIENTS AND APPEARANCE
HELIUM
helium gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:84120-001(NDC:11054-004) Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM 992 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84120-001-01 377 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 2 NDC:84120-001-02 623 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 3 NDC:84120-001-03 2143 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 4 NDC:84120-001-04 2899 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 5 NDC:84120-001-05 5689 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 6 NDC:84120-001-06 6201 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 7 NDC:84120-001-07 6338 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 8 NDC:84120-001-08 6824 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 9 NDC:84120-001-09 7481 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 10 NDC:84120-001-10 8144 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 11 NDC:84120-001-11 762 L in 1 CYLINDER; Type 0: Not a Combination Product 05/07/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205843 05/07/2024 Labeler - WSM SUPPLIER LLC. (077254165) Establishment Name Address ID/FEI Business Operations WSM SUPPLIER LLC. 077254165 relabel(84120-001)