Nitrogen Gas
FDA Label NDC 46123-440

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Roberts Oxygen Company, Inc. for the product Nitrogen (NDC 46123-440). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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



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