OXYGEN HELIUM MIXTURE 30/70 gas

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065)
Available from:
AGL Inhalation Therapy Co.
INN (International Name):
Oxygen
Composition:
Oxygen 300 mL in 1 L
Administration route:
RESPIRATORY (INHALATION)
Prescription type:
PRESCRIPTION
Authorization status:
New Animal Drug Application
Authorization number:
17575-028-01, 17575-028-02, 17575-028-03

OXYGEN HELIUM MIXTURE 30/70- oxygen helium mixture 30/70 gas

AGL Inhalation Therapy Co.

----------

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., 07015

OXYGEN HELIUM MIXTURE 30/70

oxygen helium mixture 30/70 gas

Product Information

Product T ype

PRESCRIPTION ANIMAL DRUG

Ite m Code (Source )

NDC:17575-0 28

Route of Administration

RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety

AGL Inhalation Therapy Co.

Ingredient Name

Basis of Strength

Stre ng th

O xyg en (UNII: S8 8 TT140 6 5) (Oxygen - UNII:S8 8 TT140 6 5)

Oxyge n

30 0 mL in 1 L

Inactive Ingredients

Ingredient Name

Stre ng th

Helium (UNII: 20 6 GF3GB41)

70 0 mL in 1 L

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:17575-0 28 -0 1

46 9 0 L in 1 CYLINDER

2

NDC:17575-0 28 -0 2

515 L in 1 CYLINDER

3

NDC:17575-0 28 -0 3

49 10 L in 1 CYLINDER

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NADA

NADA14136 5

0 1/0 1/19 6 6

Labeler -

AGL Inhalation T herapy Co. (011186004)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

AGL Inhalatio n Therapy Co .

0 1118 6 0 0 4

ma nufa c ture

Revised: 7/2020

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