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    Drug Product Composition: Ingenol Mebutate

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    Ingenol Mebutate

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

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    USFDA APPLICATION NUMBER - 202833 / DOSAGE - GEL;TOPICAL - 0.015%

    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)