OXYGEN by Praxair Mexico, S. de R.L. de C.V OXYGEN gas

OXYGEN by

Drug Labeling and Warnings

OXYGEN by is a Prescription medication manufactured, distributed, or labeled by Praxair Mexico, S. de R.L. de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

PRAXAIR                              Track No: 012

Haciendo nuestro planeta mds productive

Certificate of Analysis (COA)

PRAXAIR MEXICO S. de R.L. de C.V.

700 Via Matamoros drive, Garza Cantu

San Nicolas de los Garza, Nuevo Leon,

64550 Mexico

Oxygen USP NDA:                            589381                  Customer Name:              Praxair Inc – Harlingen Tx

FDA Establishment Identifier:            301258051             Praxair Number:               6010667

DUNS Number:                                 812953909

LIQUID OXYGEN USP

Batch Number:

OXMIS IC0917 MIS LOX 01 1026

Order:                   Lot Number:                                                                      Shipping Container:

98579309              OX MIS 101017 PRXM481 0053                                            481

Expiration date:                2018 01 09

This product described in this document meets the requirements of the United States Pharmacopeia 40th edition, 2017, and specifications of Praxair Mexico, S. de R.L. de C.V.

Component                        Specification                     Analytical ResultAnalytical Method1Analyzer Used

Assay                                    NLT 99.5% by volume     99.89%v/v                           Paramagnetic                    Servomex 4100

Identification                     Positive                                Positive                                Paramagnetic                    Servomex 4100

Tester’s Signature:           XXXXXXXXXXXXXXXXXXXXXX

Reviewer’s Signature:    XXXXXXXXXXXXXXXXXXXXXX

                                                Quality Assurance Reviewer

Notes:1.  Liquid oxygen produced by the air liquefaction process.

2.  Product is identified as Oxygen by way of oxygen specific paramagnetic analyzers

                3.  Product is identified as oxygen through process validation, dedicated piping and product specific CGA fittings.

Date/Time:         2017 10 10                          01:26                                                     OO/R-02-080/1-10

INGREDIENTS AND APPEARANCE

OXYGEN 
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72223-002
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72223-002-01	12310000 L in 1 CONTAINER; Type 0: Not a Combination Product	06/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA210844	06/08/2017

Labeler - Praxair Mexico, S. de R.L. de C.V (812953909)

Establishment
Name	Address	ID/FEI	Business Operations
Praxair Mexico, S. de R.L. de C.V		812953909	manufacture(72223-002)