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 is 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

Use 3 times a week on clean, dry skin.
Unscrew top to dispense product.
Apply thin layer on blackhead-prone areas.
Reattach top.
Wet product on skin to activate heat.
Massage 15-30 seconds with applicator tip, then rinse.

Inactive ingredients

magnesium sulfate • dimethicone • isononyl isononanoate • isododecane • polysilicone-11 • phenyl trimethicone • hydrogenated lecithin • acetyl glucosamine • polysorbate 20 • polysorbate 80 • polyethylene • diatomaceous earth\solum diatomeae\terre de diatomées • triethylhexanoin • pumice • bambusa arundinacea (bamboo) stem extract • peg-15/lauryl dimethicone crosspolymer • caprylyl glycol • stearyl glycyrrhetinate • water\aqua\eau • silica [iln43644]

PRINCIPAL DISPLAY PANEL - 20 ml Tube Carton

blackheads

CLINIQUE

blackhead

solutions

self-heating

blackhead

extractor

SALICYLIC ACID

ACNE MEDICATION

ALL SKIN TYPES

.68 FL.OZ.LIQ./20 ml e

Principal Display Panel

BLACKHEAD SOLUTIONS SELF-HEATING BLACKHEAD EXTRACTOR ACNE MEDICATION
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49527-061
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
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ISODODECANE (UNII: A8289P68Y2)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PUMICE (UNII: NT5NN5KL16)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49527-061-01	1 in 1 CARTON	08/30/2018
1		20 mL in 1 TUBE, WITH APPLICATOR; 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(49527-061) , label(49527-061)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics Ltd.		204132062	pack(49527-061) , label(49527-061)

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder N.V.		370151326	manufacture(49527-061) , pack(49527-061) , label(49527-061)

Name	Address	ID/FEI	Business Operations
Establishment
The Estee Lauder Inc		802599436	pack(49527-061) , label(49527-061) , manufacture(49527-061)

Name	Address	ID/FEI	Business Operations
Establishment
Northtec LLC		943871157	pack(49527-061) , label(49527-061)

Name	Address	ID/FEI	Business Operations
Establishment
PADC 1		949264774	pack(49527-061) , label(49527-061)