NDC Code(s) : 59088-851-01, 59088-851-69, 59088-851-05, 59088-851-08
Packager : PureTek Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GenRx Skin BarrierDimethicone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-851
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dimethicone(UNII: 92RU3N3Y1O)
(Dimethicone - UNII:92RU3N3Y1O) 		Dimethicone15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
KUKUI NUT OIL(UNII: TP11QR7B8R)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
C12-13 PARETH-23(UNII: J1WW1510L4)
C12-13 PARETH-3(UNII: DMC6N3419L)
SAFFLOWER OIL(UNII: 65UEH262IS)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
DIMETHICONOL (40 CST)(UNII: 343C7U75XW)
LEVOMENOL(UNII: 24WE03BX2T)
CALCIUM PANTOTHENATE(UNII: 568ET80C3D)
CARTHAMUS TINCTORIUS SEED OLEOSOMES(UNII: 9S60Q72309)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
NIACINAMIDE(UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
GINGER(UNII: C5529G5JPQ)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)(UNII: 255PIF62MS)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLHEPTYL CAPRYLATE(UNII: 991Z19V2OD)
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59088-851-69144 in 1 CARTON
1NDC:59088-851-014 mL in 1 POUCH
2NDC:59088-851-0559 mL in 1 TUBE
3NDC:59088-851-08118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/08/2013

PRINCIPAL DISPLAY PANEL

GenRx Skin Barrier Cream 4 oz image