Label: HELIUM gas
- NDC Code(s): 42602-002-01, 42602-002-02, 42602-002-03, 42602-002-04
- Packager: Norco, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated December 7, 2020
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HELIUM COMPRESSED USP LABEL
HELIUM COMPRESSED USP UN1046 NON-FLAMMABLE GAS 2 35081 (R 12/10)
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. Secure all cylinders while in storage and in use.
CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION. Store and use with adequate ventilation. Use equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Do not get liquid in eyes, on skin, or clothing. Cylinder temperature should not exceed 52 degrees C (125 degrees F). Close value after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS).
FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathingis difficult, give oxygen. Call a physician.
CAS: 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL
NORCO, INC. 1125 W. Amity Rd Boise, ID 83705 208-336-1643
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42602-002 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42602-002-01 595 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2008 2 NDC:42602-002-02 6202 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2008 3 NDC:42602-002-03 368 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2008 4 NDC:42602-002-04 142 L in 1 CYLINDER; Type 0: Not a Combination Product 09/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205819 09/01/2008 Labeler - Norco, Inc. (043694645) Registrant - Norco, Inc. (043694645) Establishment Name Address ID/FEI Business Operations Norco, Inc. 962460528 manufacture(42602-002)