Label: HELIUM gas
Contains inactivated NDC Code(s)
NDC Code(s): 48883-006-01, 48883-006-02, 48883-006-03, 48883-006-04, view more48883-006-05, 48883-006-06, 48883-006-07
- Packager: Encompass Medical & Specialty Gases, Ltd.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated December 20, 2010
If you are a consumer or patient please visit this version.
PRINCIPAL DISPLAY PANEL
HELIUM COMPRESSED, USP UN1046
NON-FLAMMABLE GAS 2 37580 (R 06/05)
Rx only. WARNING: Administration of Helium may be hazardous or contraindicated. For use only by or under 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. Use a back flow preventive device in the piping. Cylinder temperatures should not exceed 52C (125F). 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
DO NOT REMOVE THIS PRODUCT LABEL.
Cylinders must be refilled by:
Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109
CONTENTS: LTRS CU. FT.
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48883-006 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:48883-006-01 91 L in 1 CYLINDER 2 NDC:48883-006-02 144 L in 1 CYLINDER 3 NDC:48883-006-03 377 L in 1 CYLINDER 4 NDC:48883-006-04 624 L in 1 CYLINDER 5 NDC:48883-006-05 3101 L in 1 CYLINDER 6 NDC:48883-006-06 6201 L in 1 CYLINDER 7 NDC:48883-006-07 8143 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 04/15/2009 Labeler - Encompass Medical & Specialty Gases, Ltd. (963344143) Establishment Name Address ID/FEI Business Operations Encompass Medical & Specialty Gases, Ltd. 963344143 manufacture Establishment Name Address ID/FEI Business Operations Encompass Medical & Specialty Gases, Ltd. 963719286 manufacture Establishment Name Address ID/FEI Business Operations Encompass Medical & Specialty Gases, Ltd. 963719096 manufacture Establishment Name Address ID/FEI Business Operations Encompass Medical & Specialty Gases, Ltd. 963718361 manufacture