NDC Code(s) : 43479-103-12, 43479-103-52
Packager : KATE SOMERVILLE SKINCARE, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EXFOLIKATE ACNESALICYLIC ACID GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43479-103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID0.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
MONTMORILLONITE(UNII: A585MN1H2L)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN(UNII: 9F8ET54T05)
TROLAMINE(UNII: 9O3K93S3TK)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
4-CARVOMENTHENOL(UNII: L65MV77ZG6)
HYDROGENATED JOJOBA OIL, RANDOMIZED(UNII: Q47ST02F58)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
POLYACRYLAMIDE (10000 MW)(UNII: E2KR9C9V2I)
LACTIC ACID(UNII: 33X04XA5AT)
ASPERGILLUS FLAVUS VAR. ORYZAE PROTEASE(UNII: Z3GVO2327F)
COPAIFERA OFFICINALIS RESIN(UNII: 1VH544O5AT)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
BERGAMOT OIL(UNII: 39W1PKE3JI)
LAVENDER OIL(UNII: ZBP1YXW0H8)
CARAPA GUIANENSIS SEED OIL(UNII: Y82418EH2I)
ACAI OIL(UNII: Z0W6766A2W)
LAURETH-7(UNII: Z95S6G8201)
XANTHAN GUM(UNII: TTV12P4NEE)
LEMON OIL(UNII: I9GRO824LL)
GRAPEFRUIT OIL(UNII: YR377U58W9)
ALCOHOL(UNII: 3K9958V90M)
PELARGONIUM GRAVEOLENS FLOWER OIL(UNII: 3K0J1S7QGC)
GENIPA AMERICANA FRUIT(UNII: CDJ4S18PLN)
BASIL OIL(UNII: Z129UMU8LE)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
GLYCINE(UNII: TE7660XO1C)
PAPAYA(UNII: KU94FIY6JB)
PINEAPPLE(UNII: 2A88ZO081O)
HAMAMELIS VIRGINIANA LEAF(UNII: T07U1161SV)
SALIX NIGRA BARK(UNII: QU52J3A5B3)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43479-103-521 in 1 BOX
1NDC:43479-103-1260 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/22/2014

PRINCIPAL DISPLAY PANEL

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