NDC Code(s) : 49527-751-01
Packager : CLINIQUE LABORATORIES LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACNE solutions liquid MAKEUP SALICYLIC ACID LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-751
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 ACID5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
ALUMINUM OXIDE(UNII: LMI26O6933)
DISODIUM EDTA-COPPER(UNII: 6V475AX06U)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
WATER(UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
ALCOHOL(UNII: 3K9958V90M)
NYLON-12(UNII: 446U8J075B)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
TALC(UNII: 7SEV7J4R1U)
BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER(UNII: CF5W1YCX11)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
SACCHARINA LATISSIMA(UNII: 68CMP2MB55)
CALCIUM STEARATE(UNII: 776XM7047L)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
CAFFEINE(UNII: 3G6A5W338E)
GLYCERIN(UNII: PDC6A3C0OX)
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
BENTONITE(UNII: A3N5ZCN45C)
10-HYDROXYDECANOIC ACID(UNII: NP03XO416B)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
TOCOPHEROL(UNII: R0ZB2556P8)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TROMETHAMINE(UNII: 023C2WHX2V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49527-751-011 in 1 CARTON 12/04/2020
130 mL in 1 BOTTLE, PLASTIC 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 12/04/2020

LABELER - CLINIQUE LABORATORIES LLC(044475127)

REGISTRANT - Estee Lauder Companies Inc.(790802086)

Establishment
Name Address ID/FEI Business Operations
PALC 078364654 pack(49527-751), label(49527-751)

Establishment
Name Address ID/FEI Business Operations
Estee Lauder N.V. 370151326 manufacture(49527-751), pack(49527-751), label(49527-751)

Establishment
Name Address ID/FEI Business Operations
Northtec LLC 943871157 pack(49527-751), label(49527-751)

PRINCIPAL DISPLAY PANEL

PRINCIPLE DISPLAY PANEL 1 FL OZ/ 30 ML FOLDING CARTON





CLINIQUE ACNE SOLUTIONS

LIQUID MAKEUP

SALICYLIC ACID ACNE TREATMENT



1 FL OZ / 30 mL







CLINIQUE LABS DISTR

NY, NY 10022



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CLINIQUE.COM


Principal Display Panel