NDC Code(s) : 43479-105-12, 43479-105-52
Packager : KATE SOMERVILLE SKINCARE, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ANTI BAC ACNE CLEARINGBENZOYL PEROXIDE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43479-105
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE(UNII: W9WZN9A0GM)
(BENZOYL PEROXIDE - UNII:W9WZN9A0GM) 		BENZOYL PEROXIDE5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PPG-2 MYRISTYL ETHER PROPIONATE(UNII: 88R97D8U8A)
ARGANIA SPINOSA SEED(UNII: 8H7X7XB54H)
PEG-40 STEARATE(UNII: ECU18C66Q7)
SAW PALMETTO(UNII: J7WWH9M8QS)
SESAME SEED(UNII: 7Y1255HVXR)
ALCOHOL(UNII: 3K9958V90M)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
HYDROGENATED METHYL ABIETATE(UNII: A23O709X8O)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)(UNII: XRK36F13ZZ)
CARBOMER 940(UNII: 4Q93RCW27E)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CETYL ALCOHOL(UNII: 936JST6JCN)
EDETATE SODIUM(UNII: MP1J8420LU)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
CHOLESTEROL(UNII: 97C5T2UQ7J)
CERAMIDE 2(UNII: C04977SRJ5)
CERAMIDE 3(UNII: 4370DF050B)
OLEIC ACID(UNII: 2UMI9U37CP)
PALMITIC ACID(UNII: 2V16EO95H1)
SODIUM ASCORBATE(UNII: S033EH8359)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
EDETIC ACID(UNII: 9G34HU7RV0)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43479-105-521 in 1 BOX 22/06/2014
1NDC:43479-105-1250 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 06/22/2014

LABELER - KATE SOMERVILLE SKINCARE, LLC(615155533)

PRINCIPAL DISPLAY PANEL

0-UC_Anti-Bac_50mL