Label: NITROUS OXIDE gas
63978-201-04, view more63978-201-05
- Packager: Air Supply of North Texas
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 2, 2020
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PRINCIPAL DISPLAY PANEL
Non-flammable gas, 2
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. Warning: HIGH PRESSURE OXIDING LIQUID AND GAS. VIGOROUSLY ACCELERATES COMBUSTION. CAN CAUSE RAPID SUFFOCATION. CAN CAUSE ANESTHETIC EFFECTS. MAY CAUSE FROSTBITE. Avoid breathing gas. Store and use with adequate ventilation. Keep oil and grease away. Use only with equipment cleaned for oxygen and rated for cylinder pressure. Do not get liquid in eyes, on skin or clothing. Cylinder temperature should not exceed 52˚C (125˚F). Open valve slowly. Close valve after each use and when empty. Use back flow preventive device in the piping. Use in accordance with the Material Safety Data Sheet (MSDS). First Aid: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician. IN CASE OF FROSTBITE, obtain medical treatment immediately. CAS: 10024-97-2. DO NOT REMOVE THIS PRODUCT LABEL.
2829 Fort Worth Ave Dallas, TX 75211
INGREDIENTS AND APPEARANCE
nitrous oxide gas
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63978-201 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:63978-201-01 2 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2009 2 NDC:63978-201-02 7 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2009 3 NDC:63978-201-03 20 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2009 4 NDC:63978-201-04 30 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2009 5 NDC:63978-201-05 56 L in 1 CYLINDER; Type 0: Not a Combination Product 01/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA206009 01/01/2009 Labeler - Air Supply of North Texas (557254711) Establishment Name Address ID/FEI Business Operations Air Supply of North Texas 557254711 manufacture(63978-201)