NDC Code(s) : 43479-301-14, 43479-301-54
Packager : KATE SOMERVILLE SKINCARE, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ECZEMA THERAPYOATMEAL CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43479-301
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL(UNII: 8PI54V663Y)
(OATMEAL - UNII:8PI54V663Y) 		OATMEAL1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
PETROLATUM(UNII: 4T6H12BN9U)
GLYCERIN(UNII: PDC6A3C0OX)
CAPRYLYL CAPRYLATE/CAPRATE(UNII: 22MCG4RSMR)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
POLYGLYCERYL-2 MONOISOSTEARATE(UNII: 7B8OE71MQC)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
MEADOWFOAM SEED OIL FATTY ACIDS(UNII: MK2D1PBV6N)
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYL LINOLEATE(UNII: MJ2YTT4J8M)
SQUALANE(UNII: GW89575KF9)
RIBES NIGRUM SEED OIL(UNII: GKE1188837)
UNDARIA PINNATIFIDA(UNII: ICV1OK7M1S)
CENTIPEDA MINIMA WHOLE(UNII: 7F196Q97IQ)
SUNFLOWER OIL(UNII: 3W1JG795YI)
PSEUDOPTEROGORGIA ELISABETHAE(UNII: UDY3H1OUX5)
CARDIOSPERMUM HALICACABUM WHOLE(UNII: 185RQ97K0V)
TOCOPHEROL(UNII: R0ZB2556P8)
ROSEMARY(UNII: IJ67X351P9)
XANTHAN GUM(UNII: TTV12P4NEE)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
OCTYLDODECANOL(UNII: 461N1O614Y)
CETYL ALCOHOL(UNII: 936JST6JCN)
ARACHIDYL ALCOHOL(UNII: 1QR1QRA9BU)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43479-301-541 in 1 BOX
1NDC:43479-301-14120 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/18/2014

PRINCIPAL DISPLAY PANEL

Eczema_4oz carton 010614_OL