NDC Code(s) : 59078-144-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Intense Care Gold Syn-Ake Wrinkle CreamGlycerin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-144
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN9857.97 mg in 45 mL
YELLOW WAX(UNII: 2ZA36H0S2V)
(YELLOW WAX - UNII:2ZA36H0S2V) 		YELLOW WAX864.9 mg in 45 mL
Inactive Ingredients
Ingredient Name Strength
MACADAMIA OIL(UNII: 515610SU8C)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
STEARIC ACID(UNII: 4ELV7Z65AP)
PALMITIC ACID(UNII: 2V16EO95H1)
GLYCOL STEARATE SE(UNII: 6YLY96TQL6)
DIMETHICONE(UNII: 92RU3N3Y1O)
PEG-100 STEARATE(UNII: YD01N1999R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CHLORPHENESIN(UNII: I670DAL4SZ)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
TROMETHAMINE(UNII: 023C2WHX2V)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ADENOSINE(UNII: K72T3FS567)
POLYSORBATE 20(UNII: 7T1F30V5YH)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
ARGININE(UNII: 94ZLA3W45F)
ISOLEUCINE(UNII: 04Y7590D77)
GOLD(UNII: 79Y1949PYO)
NEPIDERMIN(UNII: TZK30RF92W)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
STEARETH-20(UNII: L0Q8IK9E08)
PALMITOYL PENTAPEPTIDE-4(UNII: KK181SM5JG)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
SHEA BUTTER(UNII: K49155WL9Y)
EDETATE DISODIUM(UNII: 7FLD91C86K)
HESPERIDIN METHYLCHALCONE(UNII: 4T2GVA922X)
ALCOHOL(UNII: 3K9958V90M)
SERINE(UNII: 452VLY9402)
GLUTAMIC ACID(UNII: 3KX376GY7L)
ASPARTIC ACID(UNII: 30KYC7MIAI)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
TYROSINE(UNII: 42HK56048U)
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE(UNII: 38H206R00R)
CORN(UNII: 0N8672707O)
SODIUM LACTATE(UNII: TU7HW0W0QT)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
CHLORHEXIDINE GLUCONATE(UNII: MOR84MUD8E)
LEUCINE(UNII: GMW67QNF9C)
PHENYLALANINE(UNII: 47E5O17Y3R)
XANTHAN GUM(UNII: TTV12P4NEE)
VALINE(UNII: HG18B9YRS7)
THREONINE(UNII: 2ZD004190S)
PROLINE(UNII: 9DLQ4CIU6V)
ZANTHOXYLUM PIPERITUM FRUIT PULP(UNII: 7PFC2VA251)
USNEA BARBATA(UNII: D6DVA9TCAP)
PULSATILLA KOREANA WHOLE(UNII: 5R35881OBK)
HISTIDINE(UNII: 4QD397987E)
POVIDONES(UNII: FZ989GH94E)
METHIONINE(UNII: AE28F7PNPL)
CYSTEINE(UNII: K848JZ4886)
VALYLTRYPTOPHAN(UNII: 3G64B4AFQN)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
ACETYL HEXAPEPTIDE-8(UNII: L4EL31FWIL)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
SOYBEAN OIL(UNII: 241ATL177A)
PLATINUM(UNII: 49DFR088MY)
ACETYL TETRAPEPTIDE-9(UNII: VMO8OOD3V0)
PREZATIDE COPPER(UNII: 6BJQ43T1I9)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-144-011 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 part356 01/14/2016

PRINCIPAL DISPLAY PANEL

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