Nitrous Oxide by WSM SUPPLIER LLC. NITROUS OXIDE gas

Nitrous Oxide by

Drug Labeling and Warnings

Nitrous Oxide by is a Prescription medication manufactured, distributed, or labeled by WSM SUPPLIER LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NITROUS OXIDE USP

UN1070

DO NOT REMOVE THIS LABEL.

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. Wear protective gloves, protective clothing, and either eye or face protection. In case of fire: Stop leak if safe to do so. Store locked up. Dispose of contents/container in accordance with container supplier/owner instructions. 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. Use only equipment of compatible materials of construction. Open valve slowly. Use only with equipment cleaned for oxygen service. 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

WARNING: Tis product can expose you to chemicals including Nitrous Oxide, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www. P65Warnings.ca.gov

WSM SUPPLIER LLC

3535 NW 60th Street

Miami FL 33142 (305) 455 1220

www.wsmsupplier.com

INGREDIENTS AND APPEARANCE

NITROUS OXIDE 
nitrous oxide gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 84120-003(NDC:55037-301)
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	992 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84120-003-01	1337 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
2	NDC: 84120-003-02	2978 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
3	NDC: 84120-003-03	4073 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
4	NDC: 84120-003-04	6139 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
5	NDC: 84120-003-05	8267 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
6	NDC: 84120-003-06	10090 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
7	NDC: 84120-003-07	16047 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
8	NDC: 84120-003-08	18175 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
9	NDC: 84120-003-09	535 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
10	NDC: 84120-003-10	1070 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
11	NDC: 84120-003-11	1745 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
12	NDC: 84120-003-12	711 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
13	NDC: 84120-003-13	5167 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
14	NDC: 84120-003-14	14163 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024
15	NDC: 84120-003-15	18600 L in 1 CYLINDER; Type 0: Not a Combination Product	05/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA209989	05/07/2024

Labeler - WSM SUPPLIER LLC. (077254165)

Establishment
Name	Address	ID/FEI	Business Operations
WSM SUPPLIER LLC.		077254165	relabel(84120-003)