NITROGEN by Indiana Oxygen Company Inc NITROGEN gas

NITROGEN by

Drug Labeling and Warnings

NITROGEN by is a Prescription medication manufactured, distributed, or labeled by Indiana Oxygen Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NITROGEN COMPRESSED LABEL

NITROGEN, COMPRESSED NF     UN1066

NON-FLAMMABLE GAS 2              35149 (01/15)

Rx only. WARNING: Administration of Nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practioner who is experienced in the use and administration of Nitrogen and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.  WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE, IF HEATED, MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCCATION. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for cylinder pressure. 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. FIRST AID; IF INHALED; Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. CAS: 7727-37-9 DO NOT REMOVE THIS PRODUCT LABEL

INDIANA OXYGEN COMPANY

6099 WEST CORPORATE WAY INDIANAPOLIS, IN 46278

317-290-0003

NITROGEN REFRIGERATED LIQUID LABEL

REFRIGERATED LIQUID

NITROGEN, REFRIGERATED LIQUID NF UN1977

NON-FLAMMABLE GAS 2 (R-K14) 115149

↑ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.↑

DO NOT CHANGE OR FORCE FIT CONNECTIONS.

RX ONLY

CONTENTS: ___________________________________ LTRS: ___ CU FT: ___

WARNING:         Administration of Nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Nitrogen and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.

WARNING:         CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION.

Do not handle until all safety precautions have been read and understood.

Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. Use a back-flow preventive device in the piping. DO NOT change or force fit connections.

Close valve after each use and when empty.

Always keep container in upright position.

Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID:           IF INHALED: Remove person to fresh air and keep comfortable for breathing.

IF ON SKING: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.

CAS: 7727-37-9

DO NOT REMOVE THIS PRODUCT LABEL.

INDIANA OXYGEN COMPANY

6099 West Corporate Way

Indianapolis, IN 46278

317-290-0003

NITROGEN CERTIFICATE OF ANALYSIS

Certificate of Analysis - Nitrogen NF Customer ________________________ Vendor / Supplier _____________________________ This letter is to provide you with the certification you requested for Nitrogen NF, Lot number ___________. supplied to you in cylinders / vessels by our location. These cylinders were filled in accordance with the standard operating procedures utilized for the manufacture of Medical Gases. By following these procedures, our location ensures that products are safely manufactured in compliance with FDA's Current Good Manufacturing Regulations. CAUTION: Vendor supplies this certification to customer to assist customer in ensuring compliance with 21 CFR 211.84. This certification does not eliminate customer's obligation to cmply with other portions of 21 CFR 210 and 211 including but not limited to 21 CFR 211.165 (finished product testing) for cylinders and vessels filled from these supply cylinders. These cylinders are not certified for instrument calibration purposes.

TEST/REQUIREMENT         NF SPECIFICATION             LOT ANALYSIS
IDENTIFICATION                    PASS
ODOR                                    NO APPRECIABLE ODOR
OXYGEN                               LESS THAN 1.0%
CARBON MONOXIDE             LESS THAN 10 PPM
ASSAY                                  GREATER THAN 99.0%

THE METHODOLOGY BEING USED TO PERFORM THE NF TEST FOR ASSAY IS INDICATED BELOW:

________________________ PARAMAGNETIC ANALYZER MODEL NUMBER ___________________

________________________ ELECTROCHEMICAL ANALYZER MODEL NUMBER ______________

_______________________ GAS CHROMATOGRAPHY OFFICIAL USP / NF METHOD

SUPPLIER SIGNATURE ___________________ DATE _________________

J 700 a1 (01/03) BR COMPLIANCE ASSOCIATES LLC

INGREDIENTS AND APPEARANCE

NITROGEN 
nitrogen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 48546-0003
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75)	NITROGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48546-0003-1	6400 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1975
2	NDC: 48546-0003-2	4220 L in 1 DEWAR; Type 0: Not a Combination Product	01/01/1975

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205766	01/01/1975

Labeler - Indiana Oxygen Company, Inc. (006036776)

Registrant - Indiana Oxygen Company, Inc. (006036776)

Establishment
Name	Address	ID/FEI	Business Operations
Indiana Oxygen Company, Inc.		006036776	manufacture(48546-0003)