Application Nr Approved Date Route Status External Links
NDA021835 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Clobetasol Propionate Spray, 0.05% Is A Corticosteroid Indicated For The Topical Treatment Of Moderate To Severe Plaque Psoriasis Affecting Up To 20% Body Surface Area (Bsa) In Patients 18 Years Of Age Or Older. (1.1) Limitations Of Use: Do Not Use On The Face, Axillae Or Groin. (1.2) Do Not Use If Atrophy Is Present At The Treatment Site. (1.2) Do Not Use For Rosacea Or Perioral Dermatitis. (1.2) 1.1 Indication Clobetasol Propionate Spray, 0.05% Is A Super-High Potent Topical Corticosteroid Formulation Indicated For The Treatment Of Moderate To Severe Plaque Psoriasis Affecting Up To 20% Body Surface Area (Bsa) In Patients 18 Years Of Age Or Older. Patients Should Be Instructed To Use Clobetasol Propionate Spray, 0.05% For The Minimum Amount Of Time Necessary To Achieve The Desired Results [ See Dosage And Administration (2) ]. Use In Patients Under 18 Years Of Age Is Not Recommended Because Safety Has Not Been Established And Because Numerically High Rates Of Hpa Axis Suppression Were Seen With Other Clobetasol Propionate Topical Formulations. [ See Use In Specific Populations (8.4) ]. 1.2 Limitations Of Use Clobetasol Propionate Spray, 0.05% Should Not Be Used On The Face, Axillae, Or Groin. Clobetasol Propionate Spray, 0.05% Should Not Be Used If There Is Atrophy At The Treatment Site. Clobetasol Propionate Spray, 0.05% Should Not Be Used In The Treatment Of Rosacea Or Perioral Dermatitis.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clobetasol Propionate CLOBETASOL PROPIONATE ZINC3977767

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