OXYGEN HELIUM MIXTURE 30/70- oxygen and helium gas 
AGL Inhalation Therapy Co.

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.

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oxygen helium 30/70

AGL Certified ISO 9001:2008 Inhalation Therapy Co. CLIFTON, NJ 07015 973-478-5100
NON-FLAMMABLE GAS 2 OXYDIZER 5.1
Compressed gas, oxidizing, n.o.s. (Oxygen, Helium) UN3156 Part # K2MOH Medical Gas Mixture 30% Oxygen, USP CAS: 7782-44-7 Balance Helium, USP CAS: 7440-59-7
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. DANGER: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet before use. FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. DO NOT REMOVE THIS PRODUCT LABEL For Medical Use Only. Label # AGL-8-D-124-4 01/21/16 Ver. 3.67 Volume: 4910 Liters AGL 600 Rt. 46 W CLIFTON, N.J., 07015helium oxygen seventy thirty

OXYGEN HELIUM MIXTURE 30/70 
oxygen helium mixture 30/70 gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17575-018
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen300 mL  in 1 L
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium700 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17575-018-014690 L in 1 CYLINDER; Type 0: Not a Combination Product
2NDC:17575-018-02515 L in 1 CYLINDER; Type 0: Not a Combination Product
3NDC:17575-018-034910 L in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/196602/04/2016
Labeler - AGL Inhalation Therapy Co. (011186004)
Establishment
NameAddressID/FEIBusiness Operations
AGL Inhalation Therapy Co.011186004manufacture(17575-018)

Revised: 2/2016
 
AGL Inhalation Therapy Co.