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Adrenocortical hormones or their salts or derivatives

for human use including but not limited to: Betamethasone valerate, betamethasone sodium, betamethasone phosphate, betamethasone dipropionate, budesonide, ciclesonide, clobetasone, cortisone, dexamethasone sodium, dexamethasone phosphate, dexamethasone acetate, difluprednate, fludrocortisone acetate, flunisolide, fluticasone propionate, fluticasone furoate, hydrocortisone acetate, hydrocortisone aceponate, hydrocortisone sodium, methylprednisolone acetate, methylprednisolone, methylprednisolone succinate, methylprednisolone sodium, mometasone furoate, prednisolone acetate, prednisolone sodium, prednisolone phosphate, prednisone, triamcinolone acetonide, triamcinolone hexacetonide except: (a) hydrocortisone or hydrocortisone acetate, when sold as a single medicinal ingredient in a concentration that provides 1.0% or less hydrocortisone in preparations for topical use on the skin; or (b) hydrocortisone or hydrocortisone acetate, when sold in combination with any other nonprescription medicinal ingredient that provides 1.0% or less hydrocortisone in preparations for topical use on the skin; or (c) clobetasone butyrate when sold in a concentration of 0.05% in cream preparations for topical use on the skin; or (d) triamcinolone acetonide in a nasal spray that delivers 55 microgram (mcg)/spray for those 12 years of age and older; or, (e) mometasone furoate for the treatment of allergic rhinitis in a nasal spray that delivers 50 mcg/spray for those 12 years of age and older; or (f) fluticasone propionate for the treatment of allergic rhinitis in a nasal spray that delivers 50 microgram/spray for those 18 years of age and older.

Approval Date:

Schedule: I

Footnote: PDL