NDC Code(s) : 59078-114-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Bio EX Active Cell-Whitening CreamGlycerin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-114
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN3676.9095 mg in 45 mL
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE900 mg in 45 mL
Inactive Ingredients
Ingredient Name Strength
RAFFINOSE(UNII: N5O3QU595M)
PALMITOYL PENTAPEPTIDE-4(UNII: KK181SM5JG)
ASCORBYL GLUCOSIDE(UNII: 2V52R0NHXW)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
PEG-100 STEARATE(UNII: YD01N1999R)
STEARETH-2(UNII: V56DFE46J5)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
CERAMIDE 3(UNII: 4370DF050B)
TROMETHAMINE(UNII: 023C2WHX2V)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
OCTYLDODECANOL(UNII: 461N1O614Y)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCOLIC ACID(UNII: 0WT12SX38S)
WATER(UNII: 059QF0KO0R)
PEG-150 DISTEARATE(UNII: 6F36Q0I0AC)
SUCROSE DISTEARATE(UNII: 33X4X4B90S)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
NIACINAMIDE(UNII: 25X51I8RD4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
INOSITOL(UNII: 4L6452S749)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PANTHENOL(UNII: WV9CM0O67Z)
FOLIC ACID(UNII: 935E97BOY8)
ACETIC ACID(UNII: Q40Q9N063P)
LACTIC ACID(UNII: 33X04XA5AT)
XANTHAN GUM(UNII: TTV12P4NEE)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
CHOLESTEROL(UNII: 97C5T2UQ7J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-114-011 in 1 CARTON 19/01/2016
145 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part347 01/14/2016

PRINCIPAL DISPLAY PANEL

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