OXYGEN by Air Liquide Large Industries U.S. LP OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Air Liquide Large Industries U.S. LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Oxygen USP COA

AIR LIQUIDE  OXYGEN U.S.P.         Form Number: 2A-ALL-QUA-0005-F

                                                            Revision:         0

                                                            Effective Date: 03/29/06

                                                            Page:               1/1

CERTIFICATE OF ANALYSIS

Air Liquide large Industries U.S. L.P. – Houston, TX 77056

PRODUCED BY AIR LIQUEFACTION

1.Location       Street Address1                                  2. Carrier ________________

Street Address 2

City, State Zip

3. Lot Number ______________________                4. Trailer No _____________

PRE-FILL REPORT                                                   FILL REPORT

5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate

   (>99.5% O2)                  Detected                                 loading procedure by:

   _______ %                  Yes    No                              Signature _________________________

   ________                    ________                             Date _____________________________

    Initial                            Initial

ANALYSIS REPORT

Test required             Method of Analysis                           Specifications                       Results

OXYGEN ASSAY       PARAMAGNETIC       ___                  99.5% O2 Minimum                9. ____%

                                    8.Analyzer Tag Number        

ODOR                         Organoleptic (Nasal)                           None                                       10. ______

USP applies only when used in a medical application or by medical customers properly registered with the FDA. Note: Oxygen that is produced by the air liquefaction process is exempt from the requirement of the impurity test for Carbon Dioxide and Carbon Monoxide.

11. Analyzed By         ________________________            Date ____________

12. Witnessed By       ________________________            Date ____________

     (only required for HRC customers)

13. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2

14. SQCU Review/Release _______________________     Date ____________

MANDATORY FORM

User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 11853-013
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: 11853-013-60	25000 L in 1 TANK; Type 0: Not a Combination Product	01/01/1960
2	NDC: 11853-013-61	50000 L in 1 TANK; Type 0: Not a Combination Product	01/01/1960

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205737	01/01/1960

Labeler - Air Liquide Large Industries U.S. LP (180015062)

Registrant - Air Liquide Large Industries U.S. LP (180015062)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		791294122	manufacture(11853-013)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		832290014	manufacture(11853-013)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		831993303	manufacture(11853-013)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		047089305	manufacture(11853-013)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		111765132	manufacture(11853-013)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		117158467	manufacture(11853-013)