Drug Facts

Active ingredient

Salicylic Acid 1.0%

Purpose

Acne Treatment

Uses

reduces the number of blackheads
helps keep skin clear of new blackheads
helps prevent development of new blackheads

Warnings

For external use only

When using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only one topical acne medication should be used unless directed by a doctor.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of eyes.

Directions

Apply to face daily, wet and massage, rinse off.

Inactive ingredients

water\aqua\eau • kaolin • glycerin • butylene glycol • magnesium aluminum silicate • glyceryl stearate • peg-100 stearate • silica • sodium lauroyl sarcosinate • allyl methacrylates crosspolymer • gentiana lutea (gentian) root extract • laminaria saccharina extract • sucrose • acetyl glucosamine • caprylyl glycol • 1,2-hexanediol • tocopheryl acetate • sodium hydroxide • xanthan gum • disodium edta • phenoxyethanol • titanium dioxide (ci 77891) • blue 1 (ci 42090) • yellow 5 (ci 19140) [iln43442]

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

CLINIQUE

blackhead
solutions

7 day deep pore
cleanse & scrub

SALICYLIC ACID
ACNE MEDICATION

ALL SKIN TYPES

.5 FL.OZ.LIQ./15 ml e

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

BLACKHEAD SOLUTIONS 7 DAY DEEP PORE CLEANSE AND SCRUB ACNE MEDICATION
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49527-062
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SUCROSE (UNII: C151H8M554)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49527-062-01	1 in 1 CARTON	08/30/2018	11/30/2022
1		20 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:49527-062-02	1 in 1 CARTON	08/01/2022
2		125 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M006	08/30/2018

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Name	Address	ID/FEI	Business Operations
Establishment
PALC		078364654	pack(49527-062) , label(49527-062)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics Ltd.		204132062	pack(49527-062) , label(49527-062)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder N.V.		370151326	manufacture(49527-062) , pack(49527-062) , label(49527-062)

Name	Address	ID/FEI	Business Operations
Establishment
The Estee Lauder Inc		802599436	manufacture(49527-062) , pack(49527-062) , label(49527-062)

Name	Address	ID/FEI	Business Operations
Establishment
Northtec LLC		943871157	pack(49527-062) , label(49527-062)

Name	Address	ID/FEI	Business Operations
Establishment
PADC 1		949264774	pack(49527-062) , label(49527-062)