Nitrogen by TIMS SOUTH TEXAS LLC / Tims South Texas, LLC NITROGEN gas

Nitrogen by

Drug Labeling and Warnings

Nitrogen by is a Prescription medication manufactured, distributed, or labeled by TIMS SOUTH TEXAS LLC, Tims South Texas, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NITROGEN, COMPRESSED NF

UN1066

Rx only. 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 GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. Use a back flow preventive device in the piping. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AIR: 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.

TIM’S SOUTH TEXAS

PO BOX 1555 UVALDE, TX 78802

830-278-4647

INGREDIENTS AND APPEARANCE

NITROGEN 
nitrogen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71227-002
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75)	NITROGEN	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71227-002-01	6501 L in 1 CYLINDER; Type 0: Not a Combination Product	12/11/2024
2	NDC: 71227-002-02	3298 L in 1 CYLINDER; Type 0: Not a Combination Product	12/11/2024
3	NDC: 71227-002-03	643 L in 1 CYLINDER; Type 0: Not a Combination Product	12/11/2024
4	NDC: 71227-002-04	388 L in 1 CYLINDER; Type 0: Not a Combination Product	12/11/2024
5	NDC: 71227-002-05	180 L in 1 DEWAR; Type 0: Not a Combination Product	12/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205891	12/11/2024

Labeler - TIMS SOUTH TEXAS LLC (079410611)

Establishment
Name	Address	ID/FEI	Business Operations
Tims South Texas, LLC		003895543	manufacture(71227-002)