NDC Code(s) : 69725-002-01, 69725-002-02
Packager : LIZK Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FIRST C SUPERFULLArbutin, Adenosine CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69725-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARBUTIN(UNII: C5INA23HXF)
(ARBUTIN - UNII:C5INA23HXF) 		ARBUTIN1 mg in 50 mL
ADENOSINE(UNII: K72T3FS567)
(ADENOSINE - UNII:K72T3FS567) 		ADENOSINE0.2 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST)(UNII: P0TX083987)
BETAINE(UNII: 3SCV180C9W)
MINERAL OIL(UNII: T5L8T28FGP)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
Diisostearyl Malate(UNII: QBS8A3XZGQ)
Microcrystalline Wax(UNII: XOF597Q3KY)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
Polysorbate 60(UNII: CAL22UVI4M)
PAPRIKA(UNII: X72Z47861V)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE)(UNII: W2T4YRA9AD)
NEPIDERMIN(UNII: TZK30RF92W)
MECASERMIN(UNII: 7GR9I2683O)
BASIC FIBROBLAST GROWTH FACTOR (HUMAN)(UNII: S3529G9M9V)
LUTEIN(UNII: X72A60C9MT)
Glutathione(UNII: GAN16C9B8O)
MACLURA TRICUSPIDATA BARK(UNII: XU4SO65V1I)
VISCUM ALBUM WHOLE(UNII: E6839Q6DO1)
MUNG BEAN(UNII: 1LIB31N73G)
REISHI(UNII: TKD8LH0X2Z)
TREMELLA FUCIFORMIS WHOLE(UNII: 4938BNS0GU)
BOERHAVIA DIFFUSA ROOT(UNII: KR0SR09KYL)
ALLANTOIN(UNII: 344S277G0Z)
PANTHENOL(UNII: WV9CM0O67Z)
CAFFEINE(UNII: 3G6A5W338E)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
Tocopherol(UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Dimethicone(UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
Stearic Acid(UNII: 4ELV7Z65AP)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
YELLOW WAX(UNII: 2ZA36H0S2V)
PEG-100 STEARATE(UNII: YD01N1999R)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
Phenoxyethanol(UNII: HIE492ZZ3T)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)(UNII: 1DXE3F3OZX)
ETHOHEXADIOL(UNII: M9JGK7U88V)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
CHLORPHENESIN(UNII: I670DAL4SZ)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
Trideceth-6(UNII: 3T5PCR2H0C)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
SODIUM PHOSPHATE(UNII: SE337SVY37)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69725-002-021 in 1 CARTON 03/05/2018
1NDC:69725-002-0150 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/05/2018

PRINCIPAL DISPLAY PANEL

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