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NDA021758 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1indications And Usage Vanos Cream Is A Corticosteroid Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses In Patients 12 Years Of Age Or Older. ( 1 ) Limitation Of Use: • Treatment Beyond 2 Consecutive Weeks Is Not Recommended, And The Total Dosage Should Not Exceed 60 G Per Week Because Of The Potential For The Drug To Suppress The Hypothalamic-Pituitary-Adrenal (Hpa) Axis. ( 1 ) • Avoid Use On The Face, Groin, Or Axillae. ( 1.2 ) • Avoid Use In Perioral Dermatitis Or Rosacea. ( 1.2 ) 1.1 Indications Vanos® (Fluocinonide) Cream, 0.1% Is Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses In Patients 12 Years Of Age Or Older [ See Use In Specific Populations (8.4) ]. 1.2 Limitation Of Use Treatment Beyond 2 Consecutive Weeks Is Not Recommended And The Total Dosage Should Not Exceed 60 G Per Week Because The Safety Of Vanos Cream For Longer Than 2 Weeks Has Not Been Established And Because Of The Potential For The Drug To Suppress The Hypothalamic-Pituitary-Adrenal (Hpa) Axis. Therapy Should Be Discontinued When Control Of The Disease Is Achieved. If No Improvement Is Seen Within 2 Weeks, Reassessment Of The Diagnosis May Be Necessary. Do Not Use More Than Half Of The 120 G Tube Per Week. Vanos Cream Should Not Be Used In The Treatment Of Rosacea Or Perioral Dermatitis, And Should Not Be Used On The Face, Groin, Or Axillae.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fluocinonide FLUOCINONIDE ZINC3977978

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