NDC Code(s) : 70319-012-01, 70319-012-02
Packager : COSRX inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Salicylic Acid Daily Gentle CleanserSalicylic Acid GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70319-012
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 ACID0.75 mg in 150 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
MYRISTIC ACID(UNII: 0I3V7S25AW)
STEARIC ACID(UNII: 4ELV7Z65AP)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
LAURIC ACID(UNII: 1160N9NU9U)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCOL DISTEARATE(UNII: 13W7MDN21W)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM METHYL COCOYL TAURATE(UNII: JVL98CG53G)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
PEG-60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TEA TREE OIL(UNII: VIF565UC2G)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
WILLOW BARK(UNII: S883J9JDYX)
CRYPTOMERIA JAPONICA LEAF(UNII: SCM4971GZQ)
NELUMBO NUCIFERA LEAF(UNII: 60C608DPVT)
PINUS PALUSTRIS LEAF(UNII: OT6R5143A1)
ULMUS DAVIDIANA ROOT(UNII: URQ79U8261)
OENOTHERA BIENNIS FLOWER(UNII: Y1YXJ1M6Z5)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ETHOHEXADIOL(UNII: M9JGK7U88V)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70319-012-021 in 1 PACKAGE 07/05/2017
1NDC:70319-012-01150 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 05/07/2017

PRINCIPAL DISPLAY PANEL

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