Oxygen by Indian River Oxygen, Inc. OXYGEN gas

Oxygen by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

OXYGEN, COMPRESSED USP

UN1072

PRODUCED BY AIR LIQUEFACTION

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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only be establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. 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. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use.

CAS 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL.

INDIAN RIVER OXYGEN, INC.

650 ANGLE ROAD

FORT PIERCE, FL 34947

772-461-7745

PRINCIPAL DISPLAY PANEL

OXYGEN, COMPRESSED USP

UN1072

Produced by Air Liquefaction.

CONTENTS:

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. Keep out of reach of children.

Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZIER.

CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.

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. 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. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL.

INDIAN RIVER OXYGEN, INC.

650 ANGLE ROAD

FORT PIERCE, FL 34947

772-461-7745

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 60980-002
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: 60980-002-01	2265 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003
2	NDC: 60980-002-02	3454 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003
3	NDC: 60980-002-03	6909 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003
4	NDC: 60980-002-04	9344 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003
5	NDC: 60980-002-05	5097 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003
6	NDC: 60980-002-06	240 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003
7	NDC: 60980-002-07	680 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003
8	NDC: 60980-002-08	164 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003
9	NDC: 60980-002-09	255 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003
10	NDC: 60980-002-10	425 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205865	01/01/2003

Labeler - Indian River Oxygen, Inc. (122627206)

Establishment
Name	Address	ID/FEI	Business Operations
Indian River Oxygen, Inc.		122627206	manufacture(60980-002)