WARNINGS SECTION

Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Certicate of Analysis - Nitrogen NF

Product: Nitrogen NF

Date
Facility Name
Facility Address
Lot#		Batch #

Final Analysis Results

Analyzer #	Test/Units	NF Specs	Analysis Results
N/A	Odor	None
	ppm O2	< 10,000 (Messer Spec <5.0)	ppm
	ppm CO	< 10.0	ppm
	ppm THC	N/A	ppm
	ppm H2O	N/A	ppm
	ppm CO2	N/A	ppm
	ppm H2	N/A	ppm
Assay Results	Nitrogen min %	> 99.0% (Messer Spec >99.999%)	%

NT= not tested

PPM O2 Method Used: __________________________

Manufacturer/

Model #: __________________________

PPM O2 Method Used:

__________________________

Manufacturer/Model #:

__________________________

This analyzer has been validated by Messer as acceptable alternatives to the official NF for Nitrogen Assay. Validation study documentation is maintained by Messer at the corporate offices.

Analyst	Date

Quality Reviewer	Date

Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”

NITROGEN
nitrogen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:52438-016
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Nitrogen (UNII: N762921K75) (Nitrogen - UNII:N762921K75)	Nitrogen	995 mL in 1 L

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52438-016-20	25000 L in 1 TANK; Type 0: Not a Combination Product	01/01/1960

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA205766	01/01/1960

Labeler - Messer LLC (001368141)

Registrant - Messer LLC (001368141)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		943812438	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		026946218	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		041268947	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		101889988	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		003000197	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		081695020	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		872699181	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		002123321	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		092191712	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		839692303	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		791242337	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		192602431	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		945417111	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		042263707	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		147344667	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		102835006	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		940070527	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		969312248	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		004212362	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		019983468	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		799311001	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		079481211	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		809794592	manufacture(52438-016) , api manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		108034669	api manufacture(52438-016) , manufacture(52438-016)

Name	Address	ID/FEI	Business Operations
Establishment
Messer LLC		093220150	manufacture(52438-016) , api manufacture(52438-016)

Nitrogen NF Bulk Liquid

WARNINGS SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL