Label: NITROUS OXIDE gas
- NDC Code(s): 52085-003-01, 52085-003-02, 52085-003-03
- Packager: Analgesic Services Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 29, 2025
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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. 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/containers in accordance with container supplier/user instructions. Use a back flow preventive device in the piping. Close valve after each use and when empty. 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: This product can expose you to chemicals including Nitrous Oxide, which is know to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov
ANALGESIC SERVICES, INC.
1418 N. MARKET BLVD. SUITE 300
SACRAMENTO, CA 95834 (888) 928-1068
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INGREDIENTS AND APPEARANCE
NITROUS OXIDE
nitrous oxide gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52085-003 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:52085-003-01 1745 L in 1 CYLINDER; Type 0: Not a Combination Product 04/01/2021 2 NDC:52085-003-02 8267 L in 1 CYLINDER; Type 0: Not a Combination Product 04/01/2021 3 NDC:52085-003-03 14163 L in 1 CYLINDER; Type 0: Not a Combination Product 04/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA209989 04/01/2021 Labeler - Analgesic Services Inc (017827288) Establishment Name Address ID/FEI Business Operations Analgesic Services Inc 017827288 manufacture(52085-003) Establishment Name Address ID/FEI Business Operations Analgesic Services, Inc. 117130170 manufacture(52085-003) Establishment Name Address ID/FEI Business Operations Analgesic Services Inc 117520990 manufacture(52085-003)