Label: HELIUM gas
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Contains inactivated NDC Code(s)
NDC Code(s): 58420-004-01, 58420-004-02, 58420-004-03, 58420-004-04, view more58420-004-05, 58420-004-06, 58420-004-07, 58420-004-08, 58420-004-09, 58420-004-10, 58420-004-11 - Packager: Airgas Intermountain Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated June 22, 2010
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PRINCIPAL DISPLAY PANEL
HELIUM, COMPRESSED USP
UN1046
NON-FLAMMABLE 2
30580 (05/02)
Rx only. CAUTION: Federal law prohibits dispensing without a prescription. 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.
CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION. Store and use with adequate ventilation. Use equipment rated for cylinder pressure. 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. C.A.S. : 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL.
AIRGAS PURITAN MEDICAL Distributed By: Airgas Intermountain, Inc. Denver, CO 80216 (303) 370-7800 -
INGREDIENTS AND APPEARANCE
HELIUM
helium gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58420-004 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:58420-004-01 113 L in 1 CYLINDER 2 NDC:58420-004-02 170 L in 1 CYLINDER 3 NDC:58420-004-03 227 L in 1 CYLINDER 4 NDC:58420-004-04 368 L in 1 CYLINDER 5 NDC:58420-004-05 510 L in 1 CYLINDER 6 NDC:58420-004-06 595 L in 1 CYLINDER 7 NDC:58420-004-07 1019 L in 1 CYLINDER 8 NDC:58420-004-08 2095 L in 1 CYLINDER 9 NDC:58420-004-09 3115 L in 1 CYLINDER 10 NDC:58420-004-10 5493 L in 1 CYLINDER 11 NDC:58420-004-11 8212 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1985 Labeler - Airgas Intermountain Inc (019714331) Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 072198059 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 084208433 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 943069948 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 883003915 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 090327250 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 182466243 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 054313408 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 618581441 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 859665069 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 128647740 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 020467911 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 126606222 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 847756426 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 165006818 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 149496028 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 806310637 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 946412723 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 082728627 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 791450422 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 097765218 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 190164744 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 789145745 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 611965146 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 793984089 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 790441885 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 028348386 manufacture Establishment Name Address ID/FEI Business Operations Airgas Intermountain Inc 931891407 manufacture