Label: HELIUM OXYGEN MIXTURE gas
-
Contains inactivated NDC Code(s)
NDC Code(s): 10736-013-01, 10736-013-02, 10736-013-03 - Packager: Medical-technical Gases, 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 22, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
PRINCIPAL DISPLAY PANEL
COMPRESSED GAS, N.O.S.
(80% HELIUM, USP, 20% OXYGEN, USP)
UN 1956
NON-FLAMMABLE GAS 2
RX ONLY
WARNING: Administration of this gas mixture 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 gas mixtures, 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.
WARNING: CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED. MIXTURES CONTAINING LESS THAN 19.5% OXYGEN MAY CAUSE RAPID SUFFOCATION.
Keep oil and grease away. Close valve after each use and when empty. Do not handle until all safety precautions have been read and understood. Open valve slowly. Protect from sunlight when ambient temperature exceeds 52 degrees C/125 degrees F. Store and use in a well ventilated place. Use a back flow preventive device in the piping. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. FIRST AID: IF ACCIDENTLY INHALED: If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for breathing. Call a physician. DO NOT REMOVE THIS PRODUCT LABEL.Medical-Technical Gases, Inc.
8 Executive Park Drive
North Billerica, MA
Tel 800 FINE GAS
Fax (781) 395-9098
www.medtechgases.com
-
INGREDIENTS AND APPEARANCE
HELIUM OXYGEN MIXTURE
helium oxygen mixture gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10736-013 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM 800 mL in 1 L OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 200 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10736-013-01 620 L in 1 CYLINDER 2 NDC:10736-013-02 5703 L in 1 CYLINDER 3 NDC:10736-013-03 7744 L in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 05/01/2014 Labeler - Medical-technical Gases, Inc. (019481373) Establishment Name Address ID/FEI Business Operations Medtech Gases Inc 066397297 manufacture(10736-013)