NDC Code(s) : 43479-108-12, 43479-108-52
Packager : KATE SOMERVILLE SKINCARE, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DERMAL QUENCH CLEAR ANTI-ACNE TREATMENTSALICYLIC ACID GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43479-108
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)
PROPANE(UNII: T75W9911L6)
ISOBUTANE(UNII: BXR49TP611)
PERFLEXANE(UNII: FX3WJ41CMX)
DIMETHICONE(UNII: 92RU3N3Y1O)
PROPANEDIOL(UNII: 5965N8W85T)
ISODODECANE(UNII: A8289P68Y2)
PERFLUOROPERHYDROPHENANTHRENE(UNII: ZZ3T53GWV9)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PERFLUNAFENE(UNII: 54A06VV62N)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERETH-18 ETHYLHEXANOATE(UNII: IWS58C6V2Y)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE(UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE(UNII: 2V6E5WN99N)
TROPAEOLUM MAJUS(UNII: 9G6ZOS4L87)
OAT(UNII: Z6J799EAJK)
COCAMIDOPROPYL HYDROXYSULTAINE(UNII: 62V75NI93W)
GLYCERETH-18(UNII: SA5E43C17C)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
PEG-60 ALMOND GLYCERIDES(UNII: 4Y0E651N0F)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYALURONIC ACID(UNII: S270N0TRQY)
YELLOW WAX(UNII: 2ZA36H0S2V)
SHEA BUTTER(UNII: K49155WL9Y)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PALMITOYL TRIPEPTIDE-5(UNII: 2A3916MQHO)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
PALMITIC ACID(UNII: 2V16EO95H1)
FUCUS VESICULOSUS(UNII: 535G2ABX9M)
ZINC SULFATE(UNII: 89DS0H96TB)
KAOLIN(UNII: 24H4NWX5CO)
RICE BRAN(UNII: R60QEP13IC)
INDIAN FRANKINCENSE(UNII: 4PW41QCO2M)
HONEY(UNII: Y9H1V576FH)
CARBOMER 940(UNII: 4Q93RCW27E)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
MASOPROCOL(UNII: 7BO8G1BYQU)
OLEANOLIC ACID(UNII: 6SMK8R7TGJ)
TEA TREE OIL(UNII: VIF565UC2G)
LITSEA OIL(UNII: 2XIW34BN6O)
LAVENDER OIL(UNII: ZBP1YXW0H8)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CITRAL(UNII: T7EU0O9VPP)
LINALOOL, (+)-(UNII: F4VNO44C09)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43479-108-521 in 1 BOX
1NDC:43479-108-1245 mL in 1 BOTTLE, PUMP
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

DQ CLEAR

DQ CLEAR