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Drug Product Composition: Tretinoin

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

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)