SPL Set ID: acb7d02d-249b-4645-ac1b-8ff9a56dd244

NICOTROL ® NS (nicotine nasal spray) is an aqueous solution of nicotine intended for administration as a metered spray to the nasal mucosa. Nicotine is a tertiary amine composed of pyridine and a pyrrolidine ring. It is a colorless to pale yellow, freely water-soluble, strongly alkaline, oily, volatile, hygroscopic liquid obtained from the tobacco plant. Nicotine has a characteristic pungent odor and turns brown on exposure to air or light. Of its two stereoisomers, S(-)nicotine is the more active. It is the prevalent form in tobacco and is the form in NICOTROL NS. The free alkaloid is absorbed rapidly through skin, mucous membranes, and the respiratory tract. Chemical Name: S-3-(1-methyl-2-pyrrolidinyl) pyridine Molecular Formula: C 10 H 14 N 2 Molecular Weight: 162.23 Ionization Constants: pKa 1 = 7.84, pKa 2 = 3.04 at 15°C Octanol-Water Partition Coefficient: 15:1 at pH 7 Each 10 mL spray bottle contains 100 mg nicotine (10 mg/mL) in an inactive vehicle containing disodium phosphate, sodium dihydrogen phosphate, citric acid, methylparaben, propylparaben, edetate disodium, sodium chloride, polysorbate 80, aroma and water. The solution is isotonic with a pH of 7. It contains no chlorofluorocarbons. After priming the delivery system for NICOTROL NS, each actuation of the unit delivers a metered dose spray containing approximately 0.5 mg of nicotine. The size of the droplets produced by the unit is in excess of 8 microns. One NICOTROL NS unit delivers approximately 200 applications. Chemical Structure