Label: NITROUS OXIDE gas
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NDC Code(s):
53440-003-01,
53440-003-02,
53440-003-03,
53440-003-04, view more53440-003-05
- Packager: Westair Gases & Equipment, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 10, 2023
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PRINCIPAL DISPLAY PANEL
NITROUS OXIDE USP UN1070 NON-FLAMMABLE GAS 2 OXIDIZER 5.1
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 PESSURE; MAY EXPLODE IF HEATED. MAY CUASE 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 put 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 52 degrees C (125 degrees 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. WARNING: This product contains a chemical known to the state of California to cause birth defects or other reproductive harm. CAS: 10024-97-2
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WestAir 1-866-937-8247 2506 Market Street, San Diego, CA 92102 www.westairgases.com
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INGREDIENTS AND APPEARANCE
NITROUS OXIDE
nitrous oxide gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53440-003 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 995 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53440-003-01 13815 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2000 2 NDC:53440-003-02 7400 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2000 3 NDC:53440-003-03 4934 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2000 4 NDC:53440-003-04 1653 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2000 5 NDC:53440-003-05 863 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206009 01/01/2000 Labeler - Westair Gases & Equipment, Inc. (052834694) Establishment Name Address ID/FEI Business Operations Westair Gases & Equipment, Inc. 014076344 manufacture(53440-003)