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    Drug Product Composition: Tox21_300305

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    Tox21_300305

    ACTIVE PHARMA INGREDIENTS

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    $ API Ref.Price (USD/KG) : 1,929Xls

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    USFDA APPLICATION NUMBER - 21112 / DOSAGE - CREAM;TOPICAL - 0.01%;4%;0.05%

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FLUOCINOLONE ACETONIDE(UNII: 0CD5FD6S2M)
    (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)     		FLUOCINOLONE ACETONIDE0.1mg in 1
    HYDROQUINONE(UNII: XV74C1N1AE)
    (HYDROQUINONE - UNII:XV74C1N1AE)     		HYDROQUINONE40mg in 1
    TRETINOIN(UNII: 5688UTC01R)
    (TRETINOIN - UNII:5688UTC01R)     		TRETINOIN0.5mg in 1

    Inactive Ingredients

    Ingredient Name
    Galderma Laboratories, L.P.
    ANHYDROUS CITRIC ACID(XF417D3PSL)
    BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
    CETYL ALCOHOL(936JST6JCN)
    GLYCERIN(PDC6A3C0OX)
    GLYCERYL MONOSTEARATE(230OU9XXE4)
    MAGNESIUM ALUMINUM SILICATE(6M3P64V0NC)
    METHYL GLUCETH-10(N0MWT4C7WH)
    METHYLPARABEN(A2I8C7HI9T)
    PEG-100 STEARATE(YD01N1999R)
    PROPYLPARABEN(Z8IX2SC1OH)
    SODIUM METABISULFITE(4VON5FNS3C)
    STEARIC ACID(4ELV7Z65AP)
    STEARYL ALCOHOL(2KR89I4H1Y)
    WATER(059QF0KO0R)