Oxygen by Medical Comfort Systems Inc OXYGEN gas

Oxygen by

Drug Labeling and Warnings

Oxygen by is a Prescription medication manufactured, distributed, or labeled by Medical Comfort Systems Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

OXYGEN, REFRIGERATED LIQUID USP

UN1073

CONTENTS: LITERS

CAS NO: 7782-44-7

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT.

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. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. DO NOT change or force fit connections. Avoid spills. DO not walk on or roll equipment over spills. Close valve after each use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID:

IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.

DO NOT REMOVE THIS PRODUCT LABEL.

Warning: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction.

Medical Comfort Systems Inc

112 White Oak Lane Suite A

Lexington, SC 29073

1-800-765-4697

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66365-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	998 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66365-001-01	70 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/2001
2	NDC: 66365-001-02	248 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/2001
3	NDC: 66365-001-03	415 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/2001
4	NDC: 66365-001-04	682 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/2001
5	NDC: 66365-001-05	1724 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/2001
6	NDC: 66365-001-06	3452 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/2001
7	NDC: 66365-001-07	16750 L in 1 DEWAR; Type 0: Not a Combination Product	06/01/2001
8	NDC: 66365-001-08	24950 L in 1 DEWAR; Type 0: Not a Combination Product	06/01/2001
9	NDC: 66365-001-09	29069 L in 1 DEWAR; Type 0: Not a Combination Product	06/01/2001
10	NDC: 66365-001-10	33500 L in 1 DEWAR; Type 0: Not a Combination Product	06/01/2001
11	NDC: 66365-001-11	37619 L in 1 DEWAR; Type 0: Not a Combination Product	06/01/2001
12	NDC: 66365-001-12	38300 L in 1 DEWAR; Type 0: Not a Combination Product	06/01/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205849	06/01/2001

Labeler - Medical Comfort Systems Inc (037401429)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Comfort Systems Inc		037401429	manufacture(66365-001)