Oxygen by Oxygen One, Inc. Oxygen, USP

Oxygen by

Drug Labeling and Warnings

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

Drug Details [pdf]

OXYGEN- oxygen gas 
Oxygen One, Inc.

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.

----------

Oxygen, USP

Principal for Oxygen Product

OXYGEN,

REFRIGERATED

LIQUID USP

UN 1073

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.

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65689-100
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65689-100-01	36 L in 1 DEWAR; Type 0: Not a Combination Product	08/30/2010	11/18/2022
2	NDC: 65689-100-02	41 L in 1 DEWAR; Type 0: Not a Combination Product	08/30/2010	11/18/2022
3	NDC: 65689-100-03	46 L in 1 DEWAR; Type 0: Not a Combination Product	08/30/2010	11/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		08/30/2010	11/18/2022

Labeler - Oxygen One, Inc. (118987911)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen One, Inc.		118987911	manufacture(65689-100)

Revised: 11/2022

Document Id: ee11bc36-8fb1-22bf-e053-2995a90a218a

34391-3

Set id: d2bce266-857a-7550-e053-2a95a90a0cfd

Version: 2

Effective Time: 20221122