NDC Code(s) : 69278-108-01, 69278-108-02
Packager : Gm Holdings Co., Ltd

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cellapy A.Repair PlusNiacinamide, Dimethicone, Panthenol CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69278-108
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Niacinamide(UNII: 25X51I8RD4)
(NIACINAMIDE - UNII:25X51I8RD4) 		Niacinamide1 g in 50 mL
Dimethicone(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		Dimethicone0.85 g in 50 mL
Panthenol(UNII: WV9CM0O67Z)
(PANTHENOL - UNII:WV9CM0O67Z) 		Panthenol0.1 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Butylene Glycol(UNII: 3XUS85K0RA)
OLIVE OIL(UNII: 6UYK2W1W1E)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
SHEA BUTTER(UNII: K49155WL9Y)
MEADOWFOAM SEED OIL(UNII: 412ZHA4T4Y)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CORN OIL(UNII: 8470G57WFM)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
YELLOW WAX(UNII: 2ZA36H0S2V)
Betaine(UNII: 3SCV180C9W)
GRAPEFRUIT(UNII: O82C39RR8C)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
Trehalose(UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
C12-20 ALKYL GLUCOSIDE(UNII: K67N5Z1RUA)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
SODIUM POLYACRYLATE (2500000 MW)(UNII: 05I15JNI2J)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Squalane(UNII: GW89575KF9)
CANANGA OIL(UNII: 8YOY78GNNX)
BERGAMOT OIL(UNII: 39W1PKE3JI)
ORANGE OIL(UNII: AKN3KSD11B)
PALMAROSA OIL(UNII: 0J3G3O53ST)
EUCALYPTUS OIL(UNII: 2R04ONI662)
CLOVE LEAF OIL(UNII: VCA5491KVF)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
LAVENDER OIL(UNII: ZBP1YXW0H8)
MAGNOLIA X ALBA FLOWER OIL(UNII: 8QDN200R1S)
PELARGONIUM GRAVEOLENS FLOWER OIL(UNII: 3K0J1S7QGC)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
DIOSCOREA JAPONICA TUBER(UNII: I43FCF3356)
MORINDA CITRIFOLIA LEAF(UNII: 7UOL7P5FF5)
COPTIS CHINENSIS ROOT(UNII: CXS4LJR7EL)
RHEUM PALMATUM ROOT(UNII: G025DAL7CE)
BIOSACCHARIDE GUM-1(UNII: BB4PU4V09H)
STAR ANISE FRUIT(UNII: CK15HA8438)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
POLYSORBATE 20(UNII: 7T1F30V5YH)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
Adenosine(UNII: K72T3FS567)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
C14-22 ALCOHOLS(UNII: B1K89384RJ)
NEPIDERMIN(UNII: TZK30RF92W)
CERAMIDE NP(UNII: 4370DF050B)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
BASIC FIBROBLAST GROWTH FACTOR (HUMAN)(UNII: S3529G9M9V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69278-108-021 in 1 PACKAGE 01/11/2017
1NDC:69278-108-0150 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
unapproved drug other 01/04/2017

LABELER - Gm Holdings Co., Ltd(688439958)

REGISTRANT - Gm Holdings Co., Ltd(688439958)

Establishment
Name Address ID/FEI Business Operations
Gm Holdings Co., Ltd 688439958 manufacture(69278-108)

PRINCIPAL DISPLAY PANEL

a repair plus cream