Label: NITROUS OXIDE gas
- NDC Code(s): 33335-003-01, 33335-003-02, 33335-003-03, 33335-003-04
- Packager: WELSCO, INC.
- This is a repackaged label.
- Source NDC Code(s): 12213-593
- 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
DO NOT REMOVE THIS LABEL.
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/container in accordance with container supplier/owner instructions. Use a back flow preventive device in the piping. Close valve after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. 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 POISION 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 known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
DISTRIBUTED BY:
WELSCO.
9006 CRYSTAL HILL ROAD
NORTH LITTLE ROCK, AR 72113 501-771-1204
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INGREDIENTS AND APPEARANCE
NITROUS OXIDE
nitrous oxide gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33335-003(NDC:12213-593) 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:33335-003-01 14163 L in 1 CYLINDER; Type 0: Not a Combination Product 01/02/2012 2 NDC:33335-003-02 5167 L in 1 CYLINDER; Type 0: Not a Combination Product 01/02/2012 3 NDC:33335-003-03 1745 L in 1 CYLINDER; Type 0: Not a Combination Product 01/02/2012 4 NDC:33335-003-04 1070 L in 1 CYLINDER; Type 0: Not a Combination Product 01/02/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206009 01/02/2012 Labeler - WELSCO, INC. (006357420) Establishment Name Address ID/FEI Business Operations WELSCO, INC. 006357420 relabel(33335-003) Establishment Name Address ID/FEI Business Operations WELSCO, INC. 032494783 relabel(33335-003)