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Drug Product Composition: Ingenol Mebutate

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USFDA APPLICATION NUMBER - 202833 / DOSAGE - GEL;TOPICAL - 0.05%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ingenol mebutate(UNII: 7686S50JAH)
(ingenol mebutate - UNII:7686S50JAH)
ingenol mebutate500ug in 1 | 150ug in 1

Inactive Ingredients

Ingredient Name
LEO Pharma Inc.
benzyl alcohol(LKG8494WBH)
citric acid monohydrate(2968PHW8QP)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(S38J6RZN16)
isopropyl alcohol(ND2M416302)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
water(059QF0KO0R)