Label: NITROUS OXIDE gas
- NDC Code(s): 67525-400-01, 67525-400-02, 67525-400-03, 67525-400-04
- Packager: Spectrum Gas Products, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 7, 2022
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Nitrous Oxide
NITROUS OXIDE,
USP
Rx ONLY
UN1070
NON-FLAMMABLE GAS 2 SGP-26 OXIDIZER 5.1
Spectrum Gas Products
2381 E. Winston Road
Anaheim, CA 92806
Rx only. WARNING: Administration of Nitrous Oxide may be hazardous or contraindicated. For use only by or under 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 rad and understood. Keep and store away from clothing and other combustible materials. Keep valves ad 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 52oC (125oF). 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.
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INGREDIENTS AND APPEARANCE
NITROUS OXIDE
nitrous oxide gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67525-400 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 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67525-400-01 1482 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2005 2 NDC:67525-400-02 4942 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2005 3 NDC:67525-400-03 7413 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2005 4 NDC:67525-400-04 12356 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206009 01/01/2005 Labeler - Spectrum Gas Products, Inc (195875179) Establishment Name Address ID/FEI Business Operations Spectrum Gas Products, Inc 195875179 manufacture(67525-400)