Oxygen by Home Care Equipment, Inc. OXYGEN gas

Oxygen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Principal for Oxygen Product

OXYGEN

COMPRESSED

USP

UN 1072

PRODUCED BY AIR LIQUIFICATION

WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.

WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

WARNING: Federal law prohibits dispensing without prescription. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing, unless used in conjuction with resuscitative equipment.

WARNING: Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.

USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

DO NOT REMOVE THIS PRODUCT LABEL.

OXYGEN,

REFRIGERATED

LIQUID USP

UN 1073

CONTENTS ________________LITERS

CAS NO: 7782-44-7

DANGER:

REFRIGERATED LIQUEFIED OXIDIZING GAS. ALWAYS

KEEP CONTAINER IN UPRIGHT POSITION. DO NOT

CHANGE OR FORCE FIT CONNECTIONS. 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 get in eyes, on skin, or on clothing. Keep reduction valves free

from grease and oil. In case of fire, stop leak if safe to do so. Avoid

spills. Do not walk or roll equipment over spills. Store and use in a well

ventilated place. Use only with equipment of compatible materials

of construction and rated for cylinder pressure. Wear cold insulating

gloves/face sheild/eye protection. Protect from sunlight when ambient

temperature exceeds 52 F. Container temperature should

not exceed 52 F. Close valve after each use and when

empty. Use a back flow preventative device in the piping. Do not

handle until all safety precautions have been read and understood.

Use only with equipment cleaned for oxygen service. Keep/store away

from combustible materials. Do not drop. Use suitable hand truck for

container movement.

FIRST AID:

IN CASE OF FROSTBITE: Thaw frosted parts with lukewarm water.

Do not rub affected area. Get immediate medical advice/attention.

DO NOT REMOVE THIS PRODUCT LABEL.

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. Use only with pressure

reducing equipment and apparatus designed for oxygen. Do not

attempt to use on patients who have stopped breathing unless used in

conjunction with resuscitative equipment. Produced by Air Liquefaction.

ALWAYS KEEP CONTAINER IN UPRIGHT POSITION

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 57959-123
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: 57959-123-01	21.1 L in 1 DEWAR; Type 0: Not a Combination Product	12/02/2015
2	NDC: 57959-123-04	170 L in 1 CYLINDER; Type 0: Not a Combination Product	12/12/2015
3	NDC: 57959-123-05	415 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2015
4	NDC: 57959-123-06	682 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2015
5	NDC: 57959-123-08	6910 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2015
6	NDC: 57959-123-09	45 L in 1 DEWAR; Type 0: Not a Combination Product	12/02/2015
7	NDC: 57959-123-10	60 L in 1 DEWAR; Type 0: Not a Combination Product	12/02/2015
8	NDC: 57959-123-11	145 L in 1 DEWAR; Type 0: Not a Combination Product	12/02/2015
9	NDC: 57959-123-12	3455 L in 1 CYLINDER; Type 0: Not a Combination Product	12/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		12/02/2015

Labeler - Home Care Equipment, Inc. (036146249)

Registrant - Home Care Equipment, Inc. (036146249)

Establishment
Name	Address	ID/FEI	Business Operations
Home Care Equipment, Inc.		007145514	manufacture(57959-123)

Establishment
Name	Address	ID/FEI	Business Operations
Home Care Equipment, Inc.		036146249	manufacture(57959-123)

Establishment
Name	Address	ID/FEI	Business Operations
Home Care Equipment, Inc.		829110860	manufacture(57959-123)