FDA Label for Nitrogen
View Indications, Usage & Precautions
Nitrogen Product Label
The following document was submitted to the FDA by the labeler of this product Roberts Oxygen Company, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Package Label.Principal Display Panel
ROBERTS OXYGEN
ROCKVILLE, MARYLAND 20866
TEL: (301) 948-8100
CERTIFICATE OF ANALYSIS
NITROGEN REFRIGERATED LIQUID, NF*
PRODUCED BY AIR-LIQUEFACTION PROCESS
TRAILER#: ______________
DATE: _________________
LOT#: _________________
*NF applies only when used in a medical application or by medical customers properly registered with the FDA.
Component Test Method Limit Result
NITROGEN DIFF >99.999% _______
OXYGEN ________ <3.0 PPM _______
Odor ORGANOLEPTIC N/D ______
________ _________ _________ _________
Product is identified as NITROGEN, NF through process validations, dedicated piping, and product specific connections.
Notes: _____________________________________
RELEASED BY: ____________________________
SIGNATURE
RELEASED BY: ____________________________
PRINTED NAME
Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP
(800) 327-6868 *jjkeller.com * Printer in the Unitied States
* Please review the disclaimer below.