NDC Code(s) : 49527-723-01, 49527-723-02, 49527-723-03
Packager : CLINIQUE LABORATORIES LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACNE solutions CLARIFYINGSALICYLIC ACID LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-723
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 ACID15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
NYLON-12(UNII: 446U8J075B)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK(UNII: T7S323PKJS)
SACCHARINA LATISSIMA(UNII: 68CMP2MB55)
CAFFEINE(UNII: 3G6A5W338E)
SUCROSE(UNII: C151H8M554)
GLYCERIN(UNII: PDC6A3C0OX)
N-ACETYLGLUCOSAMINE(UNII: V956696549)
SORBITOL(UNII: 506T60A25R)
PSEUDOPTEROGORGIA ELISABETHAE(UNII: UDY3H1OUX5)
BARIUM SULFATE(UNII: 25BB7EKE2E)
10-HYDROXYDECANOIC ACID(UNII: NP03XO416B)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49527-723-011 in 1 CARTON 09/01/2006
1200 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:49527-723-021 in 1 CARTON 03/02/2022
260 mL in 1 BOTTLE Type 0: Not a Combination Product
3NDC:49527-723-03100 mL in 1 BOTTLE Type 0: Not a Combination Product20/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 09/01/2006

LABELER - CLINIQUE LABORATORIES LLC(044475127)

REGISTRANT - Estee Lauder Companies Inc.(790802086)

Establishment
Name Address ID/FEI Business Operations
The Estee Lauder Inc 802599436 manufacture(49527-723), pack(49527-723), label(49527-723)

Establishment
Name Address ID/FEI Business Operations
NORTHTEC KEYSTONE 949264774 label(49527-723), pack(49527-723)

Establishment
Name Address ID/FEI Business Operations
PALC 078364654 label(49527-723), pack(49527-723)

PRINCIPAL DISPLAY PANEL

CLINIQUE

acne solutions

clarifying lotion

STEP 2
SALICYLIC ACID ACNE MEDICATION

6.7 FL.OZ./200 ml e

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Carton