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Nicotine or its salts

For human use - EXCEPT: (a) in natural substances; (b) in the form of a chewing gum containing 4 mg or less of nicotine per dosage unit; (c) in the form of a transdermal patch with a delivery rate of 22 mg or less of nicotine per day; (d) in a form to be administered into the oral cavity by means of a non-active device (one that operates on energy generated by the human body or by gravity) that delivers 4 mg or less of nicotine per dose for buccal absorption; or (e) in the form of a lozenge containing 4 mg or less of nicotine per dosage unit).

Approval Date:

Schedule: I

Footnote: PDL