Label: NITROUS OXIDE SEDARA- nitrous oxide gas
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Contains inactivated NDC Code(s)
NDC Code(s): 25373-703-01 - Packager: Linde Gas & Equipment Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
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Drug Label Information
Updated December 14, 2021
If you are a consumer or patient please visit this version.
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OTHER SAFETY INFORMATION
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.
RX ONLY
LPH040E
U.S. patent pending -
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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 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. 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°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.
THE LINDE GROUP
LINDE
Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd.
Suite 7000
Bridgewater, NJ 08807
866.543.3427
MEDICAL GAS
For Use With SEDARA® Gas Mixer
NITROUS OXIDE
USP
UN 1070
CAS 10024-97-2
Content: 115 liters
Do Not Remove this Label
Batch Code
NON-FLAMMABLE GAS 2
OXIDIZER 5.1
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Use in accordance with the Safety Data Sheet for this product.
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INGREDIENTS AND APPEARANCE
NITROUS OXIDE SEDARA
nitrous oxide gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25373-703 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:25373-703-01 115 L in 1 CYLINDER; Type 0: Not a Combination Product 06/18/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 06/18/2012 Labeler - Linde Gas & Equipment Inc. (805568339) Registrant - Linde Gas & Equipment Inc. (805568339) Establishment Name Address ID/FEI Business Operations Linde Gas & Equipment Inc. 833132561 manufacture(25373-703)