Nitrous Oxide by MAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC NITROUS OXIDE gas

Nitrous Oxide by

Drug Labeling and Warnings

Nitrous Oxide by is a Prescription medication manufactured, distributed, or labeled by MAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NITROUS OXIDE USP

UN1070

RX Only. WARNING: Administration of Nitrous Oxide 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 Nitrous Oxide 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. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY CAUSE FROSTBITE. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Avoid breathing gas. Do not get in eyes, on skin or on clothing. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or doctor/physician if you feel unwell. IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention. CAS: 10024-97-2 DO NOT REMOVE THIS PRODUCT LABEL.

Maverick Oxygen & Respiratory Equipment, LLC

2510 Allen Lane. La Grange, KY 40031

502-225-4772

CONTENTS:

LTRS:

CU.FT.

INGREDIENTS AND APPEARANCE

NITROUS OXIDE 
nitrous oxide gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 67477-002
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029)	NITROUS OXIDE	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67477-002-01	12300 L in 1 CYLINDER; Type 0: Not a Combination Product	12/26/2019
2	NDC: 67477-002-02	4920 L in 1 CYLINDER; Type 0: Not a Combination Product	12/26/2019
3	NDC: 67477-002-03	1476 L in 1 CYLINDER; Type 0: Not a Combination Product	12/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA209989	12/26/2019

Labeler - MAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC (119690589)

Establishment
Name	Address	ID/FEI	Business Operations
MAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC		119690589	manufacture(67477-002)