OXYGEN HELIUM MIXTURE 30/70 GAS [AGL INHALATION THERAPY CO.]

OXYGEN HELIUM MIXTURE 30/70 GAS [AGL INHALATION THERAPY CO.]
PDF | XML

NDC 17575-038-01, 17575-038-02, 17575-038-03
Set ID 3c799e75-d974-4f9d-bd47-0ffbd05b8b98
Category HUMAN PRESCRIPTION DRUG LABEL
Packager AGL Inhalation Therapy Co.
Generic Name
Product Class
Product Number
Application Number NDA205767
  • PRINCIPAL DISPLAY PANEL

    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., 07015 helium oxygen seventy thirty

  • INGREDIENTS AND APPEARANCE
    OXYGEN HELIUM MIXTURE 30/70 
    oxygen helium mixture 30/70 gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17575-038
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN300 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    HELIUM (UNII: 206GF3GB41) 700 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17575-038-014690 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1966
    2NDC:17575-038-02515 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1966
    3NDC:17575-038-034910 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1966
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20576701/01/1966
    Labeler - AGL Inhalation Therapy Co. (011186004)
    Establishment
    NameAddressID/FEIBusiness Operations
    AGL Inhalation Therapy Co.011186004manufacture(17575-038)

Related Drugs