NDC Code(s) : 49527-713-01
Packager : CLINIQUE LABORATORIES LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACNE solutions oil CONTROL CLEANSING MASK SALICYLIC ACID CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-713
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 ACID10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
WATER(UNII: 059QF0KO0R)
KAOLIN(UNII: 24H4NWX5CO)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
SODIUM LAUROYL SARCOSINATE(UNII: 632GS99618)
GLYCERYL STEARATE CITRATE(UNII: WH8T92A065)
PEG-100 STEARATE(UNII: YD01N1999R)
GENTIANA LUTEA ROOT(UNII: S72O3284MS)
SACCHARINA LATISSIMA(UNII: 68CMP2MB55)
SUCROSE(UNII: C151H8M554)
AGAR, UNSPECIFIED(UNII: 89T13OHQ2B)
ALOE(UNII: V5VD430YW9)
DISODIUM ACETYL GLUCOSAMINE PHOSPHATE(UNII: SC89MF712W)
INULIN(UNII: JOS53KRJ01)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
XANTHAN GUM(UNII: TTV12P4NEE)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CHLORPHENESIN(UNII: I670DAL4SZ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49527-713-011 in 1 CARTON 12/10/2020
1100 mL in 1 TUBE 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 12/10/2020 05/10/2026

LABELER - CLINIQUE LABORATORIES LLC(044475127)

REGISTRANT - Estee Lauder Companies Inc.(790802086)

Establishment
Name Address ID/FEI Business Operations
PALC 078364654 pack(49527-713), label(49527-713)

Establishment
Name Address ID/FEI Business Operations
Estee Lauder Cosmetics Ltd. 204132062 pack(49527-713), label(49527-713)

Establishment
Name Address ID/FEI Business Operations
Whitman Laboratories Ltd. 216866277 manufacture(49527-713), pack(49527-713), label(49527-713)

Establishment
Name Address ID/FEI Business Operations
Estee Lauder N.V. 370151326 manufacture(49527-713), pack(49527-713), label(49527-713)

Establishment
Name Address ID/FEI Business Operations
The Estee Lauder Inc 802599436 manufacture(49527-713), pack(49527-713), label(49527-713)

Establishment
Name Address ID/FEI Business Operations
Northtec LLC 943871157 pack(49527-713), label(49527-713)

Establishment
Name Address ID/FEI Business Operations
PADC 1 949264774 pack(49527-713), label(49527-713)

PRINCIPAL DISPLAY PANEL

acne

CLINIQUE

acne solutions

oil-control

cleansing mask

SALICYLIC ACID

ACNE MEDICATION

ALL SKIN TYPES

3.4 FL.OZ.LIQ./100 ml ℮

Principal Display Panel