Label: HELIUM gas
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Contains inactivated NDC Code(s)
NDC Code(s): 46123-008-01, 46123-008-02, 46123-008-03, 46123-008-04, view more46123-008-05, 46123-008-06, 46123-008-07 - Packager: Roberts Oxygen Company, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 19, 2020
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PRINCIPAL DISPLAY PANEL
HELIUM,
COMPRESSED
USP
UN1046
NON-FLAMMABLE GAS 2
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 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 preventative 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 52ºC (125ºF). 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: 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
HELIUM
helium gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46123-008 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:46123-008-01 102 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 2 NDC:46123-008-02 374 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 3 NDC:46123-008-03 623 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 4 NDC:46123-008-04 3880 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 5 NDC:46123-008-05 5436 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 6 NDC:46123-008-06 6910 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 7 NDC:46123-008-07 8241 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/1967 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205864 01/01/1967 Labeler - Roberts Oxygen Company, Inc. (042646877) Establishment Name Address ID/FEI Business Operations Roberts Oxygen Company, Inc. 791818008 manufacture(46123-008)