Label: HELIUM gas
Contains inactivated NDC Code(s)
NDC Code(s): 61095-300-01, 61095-300-02, 61095-300-03
- Packager: GT Industries Inc
- 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.
Drug Label Information
Updated May 25, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
PRINCIPAL DISPLAY PANEL
HELIUM, COMPRESSED U.S.P.
NON-FLAMMABLE GAS 2
WARNING: SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT 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. Use in accordance with the MSDS and the precautions recommended by the supplier. DO NOT REMOVE THIS PRODUCT LABEL. GT INDUSTRIES 800 RAVIA RD. SULPHUR, LA 70663 PH# 318-583-9278 EMERGENCY PHONE 1-800-641-4357
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61095-300 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:61095-300-01 622 L in 1 CYLINDER 2 NDC:61095-300-02 368 L in 1 CYLINDER 3 NDC:61095-300-03 651 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1994 Labeler - GT Industries Inc (844779546) Establishment Name Address ID/FEI Business Operations GT Industries Inc 844779546 manufacture