Product manufactured by Leo Pharma Inc.

Application Nr Approved Date Route Status External Links
NDA050777 2000-12-08 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Protopic Ointment, Both 0.03% And 0.1% For Adults, And Only 0.03% For Children Aged 2 To 15 Years, Is Indicated As Second-Line Therapy For The Short-Term And Non-Continuous Chronic Treatment Of Moderate To Severe Atopic Dermatitis In Non-Immunocompromised Adults And Children Who Have Failed To Respond Adequately To Other Topical Prescription Treatments For Atopic Dermatitis, Or When Those Treatments Are Not Advisable. Protopic Ointment Is Not Indicated For Children Younger Than 2 Years Of Age (see Boxed Warning, Warnings And Precautions: Pediatric Use).

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Paraffin PARAFFIN Unresolved
2. Propylene Carbonate PROPYLENE CARBONATE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tacrolimus TACROLIMUS ZINC85537027