Nitrous Oxide by Roberts Oxygen Company, Inc. NITROUS OXIDE gas

Nitrous Oxide by

Drug Labeling and Warnings

Nitrous Oxide by is a Prescription medication manufactured, distributed, or labeled by Roberts Oxygen Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NITROUS OXIDE
USP
UN1070
NON-FLAMMABLE GAS 2
OXIDIZER 5.1
Rx Only. WARNING: Administration of Nitrous Oxide USP 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 USP and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and 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 CUASE 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 fitting 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 preventative 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.
Roberts Oxygen Company, Inc
PO BOX 5507 Rockville, MD 20855
301-948-8100

INGREDIENTS AND APPEARANCE

NITROUS OXIDE 
nitrous oxide gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 46123-006
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: 46123-006-01	247 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
2	NDC: 46123-006-02	990 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
3	NDC: 46123-006-03	1232 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
4	NDC: 46123-006-04	1590 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
5	NDC: 46123-006-05	2464 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
6	NDC: 46123-006-06	3710 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
7	NDC: 46123-006-07	4944 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
8	NDC: 46123-006-08	7391 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
9	NDC: 46123-006-09	7570 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
10	NDC: 46123-006-10	13797 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967
11	NDC: 46123-006-11	16066 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1967

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA206009	01/01/1967

Labeler - Roberts Oxygen Company, Inc. (042646877)

Establishment
Name	Address	ID/FEI	Business Operations
Roberts Oxygen Company, Inc.		791818008	manufacture(46123-006)