NITROUS OXIDE- nitrous oxide gas 
Roberts Oxygen Company, Inc.

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Nitrous Oxide -006

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

image of label

NITROUS OXIDE 
nitrous oxide gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-006
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE990 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46123-006-01247 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
2NDC:46123-006-02990 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
3NDC:46123-006-031232 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
4NDC:46123-006-041590 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
5NDC:46123-006-052464 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
6NDC:46123-006-063710 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
7NDC:46123-006-074944 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
8NDC:46123-006-087391 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
9NDC:46123-006-097570 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
10NDC:46123-006-1013797 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
11NDC:46123-006-1116066 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20600901/01/1967
Labeler - Roberts Oxygen Company, Inc. (042646877)
Establishment
NameAddressID/FEIBusiness Operations
Roberts Oxygen Company, Inc.791818008manufacture(46123-006)

Revised: 11/2023
Document Id: 0a4a95ed-fd1a-edd2-e063-6394a90a59e4
Set id: 988190eb-1449-482c-8120-c1d1390e2442
Version: 8
Effective Time: 20231116
 
Roberts Oxygen Company, Inc.