Label: HELIUM gas
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Contains inactivated NDC Code(s)
NDC Code(s): 10678-004-01, 10678-004-02, 10678-004-03, 10678-004-04 - Packager: Airgas-West, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated May 25, 2010
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PRINCIPAL DISPLAY PANEL
HELIUM, COMPRESSED USP
UN1046
DO NOT REMOVE THIS PRODUCT LABEL.
NON-FLAMMABLE 2
836580 (12/04)
Rx only.
CAUTION: Federal law prohibits dispensing without a prescription. WARNING: Administration of Helium may be hazardous or contraindicated. For use 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.
CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION. Store and use with adequate ventilation. Use only with equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52oC(125oF). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). Inhaling Helium to alter the voice may prove fatal and should not be permitted.
FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician. CAS: 7440-59-7
AIRGAS PURITAN MEDICAL Distributed By: Airgas West, Inc. Lakewood, CA 90712 (562) 497-1991
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INGREDIENTS AND APPEARANCE
HELIUM
helium gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10678-004 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:10678-004-01 2265 L in 1 CYLINDER 2 NDC:10678-004-02 3539 L in 1 CYLINDER 3 NDC:10678-004-03 5663 L in 1 CYLINDER 4 NDC:10678-004-04 8495 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 05/23/1947 Labeler - Airgas-West, Inc. (805645793) Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 959837287 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 807025564 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 059820498 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 869324756 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 182365809 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 026366021 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 834717514 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 879945632 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 017427142 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 170564608 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 603878740 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 802299169 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 156072928 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 949045181 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 006136793 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 786280862 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 119883507 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 832997998 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 806715392 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 033485566 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 152936519 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 927773168 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 103079992 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 156216350 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 832997881 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 832997782 manufacture Establishment Name Address ID/FEI Business Operations Airgas-West, Inc. 959935354 manufacture