NDC Code(s) : 59078-145-01, 59078-145-02
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 PerfectorGlycerin INJECTABLE FOAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-145
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE912.96 mg in 15 mL
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN2171.775 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)(UNII: 1DXE3F3OZX)
PALMITIC ACID(UNII: 2V16EO95H1)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
STEARIC ACID(UNII: 4ELV7Z65AP)
ISOHEXADECANE(UNII: 918X1OUF1E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ISOCETETH-10(UNII: 1K92T9919H)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
ALCOHOL(UNII: 3K9958V90M)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
GOLD(UNII: 79Y1949PYO)
GLYCINE(UNII: TE7660XO1C)
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE(UNII: 38H206R00R)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SERINE(UNII: 452VLY9402)
GLUTAMIC ACID(UNII: 3KX376GY7L)
CORN(UNII: 0N8672707O)
SODIUM LACTATE(UNII: TU7HW0W0QT)
CHLORHEXIDINE GLUCONATE(UNII: MOR84MUD8E)
ASPARTIC ACID(UNII: 30KYC7MIAI)
LEUCINE(UNII: GMW67QNF9C)
ALANINE(UNII: OF5P57N2ZX)
ARGININE(UNII: 94ZLA3W45F)
TYROSINE(UNII: 42HK56048U)
ADENOSINE(UNII: K72T3FS567)
THREONINE(UNII: 2ZD004190S)
ISOLEUCINE(UNII: 04Y7590D77)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
TROMETHAMINE(UNII: 023C2WHX2V)
LYSINE(UNII: K3Z4F929H6)
USNEA BARBATA(UNII: D6DVA9TCAP)
VALYLTRYPTOPHAN(UNII: 3G64B4AFQN)
PHENYLALANINE(UNII: 47E5O17Y3R)
XANTHAN GUM(UNII: TTV12P4NEE)
VALINE(UNII: HG18B9YRS7)
PROLINE(UNII: 9DLQ4CIU6V)
ZANTHOXYLUM PIPERITUM FRUIT PULP(UNII: 7PFC2VA251)
PULSATILLA KOREANA WHOLE(UNII: 5R35881OBK)
HISTIDINE(UNII: 4QD397987E)
POVIDONES(UNII: FZ989GH94E)
METHIONINE(UNII: AE28F7PNPL)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
ACETYL HEXAPEPTIDE-8(UNII: L4EL31FWIL)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
SOYBEAN OIL(UNII: 241ATL177A)
PREZATIDE COPPER(UNII: 6BJQ43T1I9)
NEPIDERMIN(UNII: TZK30RF92W)
CYSTEINE(UNII: K848JZ4886)
WATER(UNII: 059QF0KO0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
POLYSORBATE 60(UNII: CAL22UVI4M)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CHLORPHENESIN(UNII: I670DAL4SZ)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ISOCETETH-25(UNII: 0SM2NCP8P1)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TROLAMINE(UNII: 9O3K93S3TK)
HESPERIDIN METHYLCHALCONE(UNII: 4T2GVA922X)
STEARETH-20(UNII: L0Q8IK9E08)
PLATINUM(UNII: 49DFR088MY)
ACETYL TETRAPEPTIDE-9(UNII: VMO8OOD3V0)
PALMITOYL PENTAPEPTIDE-4(UNII: KK181SM5JG)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-145-011 in 1 CARTON 27/01/2016
115 mL in 1 APPLICATOR Type 0: Not a Combination Product
2NDC:59078-145-021 in 1 CARTON 27/01/2016
230 mL in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/14/2016

PRINCIPAL DISPLAY PANEL

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