EX-OX Labels

WARNING: CYLINDER WITH HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. Secure cylinder and provide adequate ventilation in storage and use. Keep oil and grease away. No smoking in cylinder area. Do not use or store near heat or open flame. Keep out of reach of children. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Cylinder temperatures should not exceed 125°F (52°C). Open valve slowly. Use in accordance with Material Safety Data Sheet and CGA Publication P-1.

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. 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.

CAUTION: Federal law prohibits dispensing without prescription. Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug producer in accordance with the Federal Food, Drug, and Cosmetic Act. Produced by Air Liquefaction.

CAUTION: USE NO OIL ON VALVE OR CONNECTIONS.

DO NOT REMOVE THIS EZ-OX PRODUCT LABEL.

Instruction_Label

Sidewall_Label

Warning_Label

EZ-OX
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64735-100
Route of Administration	RESPIRATORY (INHALATION)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64735-100-04	708 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1960	10/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA205712	01/01/1960	10/01/2016

Labeler - Air Liquide Healthcare America Corporation (087757167)

Registrant - Air Liquide Healthcare America Corporation (087757167)

Name	Address	ID/FEI	Business Operations
Establishment
Air Liquide Healthcare America Corporation		067631762	manufacture(64735-100)

Name	Address	ID/FEI	Business Operations
Establishment
Air Liquide Healthcare America Corporation		026523431	manufacture(64735-100)

Name	Address	ID/FEI	Business Operations
Establishment
Air Liquide Healthcare America Corporation		023215130	manufacture(64735-100)

Name	Address	ID/FEI	Business Operations
Establishment
Air Liquide Healthcare America Corporation		963593863	manufacture(64735-100)

Name	Address	ID/FEI	Business Operations
Establishment
Air Liquide Healthcare America Corporation		831996546	manufacture(64735-100)

Name	Address	ID/FEI	Business Operations
Establishment
Air Liquide Industrial U. S. LP		831995829	manufacture(64735-100)

Revised: 10/2016

Document Id: 806e83aa-7880-4105-80a9-f6f112076b37

Set id: 65bba1b2-50ef-4904-a7ed-715d23aec53e

Version: 6

Effective Time: 20161003

Air Liquide Healthcare America Corporation