Nitrogen Gas
FDA Label NDC 71408-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ineos Pigments Asu Llc for the product Nitrogen (NDC 71408-003). 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 nitrogen, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Nitrogen

Certificate of Analysis                    Shipped From:

                                                                                                                Ashtabula Oxygen

                                                                                                                2501 Middle Rd.

                                                                                                                Ashtabula, Ohio                              

                                                                                                                Phone: (440) 994-1994

Company Name: TEST

Product:               Nitrogen

Load No:              5                                                                                              Trailer No:          0000

Time In:               16:44:58               Time Out:            16:46:04               Load Date:          12/26/2017

Tare Weight:     0                              Gross Weight:   0           lbs           Net Weight:       0    lbs

Lot Number:      4004N17360050000                                         Produced by: Air Liquefaction

  Assay per NF requirements is by difference of O2 only

Ashtabula Oxygen

ResultsUnitsSpecifications

Purity Pre-Fill:                  PASS                                                                      Pass*

Purity Post-Fill:                99.99                     %                            >=99.999%

Assay, By Difference)

O2:                                                                         ppm/V                  <=2.0ppm

  O2 Tested By: Teledyne 3000TA-XL Electrochemcial

CO:                                                                         ppm/V                  <=5.0ppm

  CO Tested By: Teledyne GFC-7001T Non-Dispersive Infrared

H2O:                                                                      ppm/V                  <=2.0ppm

  H20 Tested By: Teledyne 8800A Electrochemcial

Odor:                                                                    None                     None

  Odor Tested By: Organoleptic

  • The Pre-Fill is tested against Ashtabula Oxygen and USP/NF specification and a “Pass” indicated that the results met and exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

    • Ashtabula Oxygen Analyst: I declare that this analysis was completed with all Ashtabula Oxygen policy and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

    Signed:         Date/Time:

    Product Release Specialist/Release By: I declare that this certification is accurate, complete and compliant with all applicable policies and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

    Signed:         Date/Time:

    Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a MSDS.

    Signed:         Date/Time:

* Please review the disclaimer below.