ACNE SOLUTIONS CLINICAL CLEARING GEL- salicylic acid gel

ACNE SOLUTIONS by

Drug Labeling and Warnings

ACNE SOLUTIONS by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Estee Lauder N.V., The Estee Lauder Inc, NORTHTEC KEYSTONE, Northtec LLC, PALC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

• treats acne
• clears acne blemishes
• helps prevent development of new acne blemishes

Warnings

For external use only

When using this productusing other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep out of reach of children.

If product is swallowed, call a doctor or contact a Poison Control Center right away.

Directions

• apply a thin layer to entire face twice a day after cleansing
• avoid eye area
• spot-apply if you are using another leave-on acne treatment
• if bothersome dryness or peeling occurs, reduce usage to every other day

Inactive ingredients

alcohol denat.,hamamelis virginiana (witch hazel) water,alcohol,acrylates/c10-30 alkyl acrylate crosspolymer,water\aqua\eau,laminaria saccharina extract,butylene glycol,benzalkonium chloride <iln52627>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

acne

CLINIQUE

acne solutions
clinical

clearing gel

SALICYLIC ACID
ACNE MEDICATION

ALL SKIN TYPES

1 FL.OZ.LIQ./30 ml e

INGREDIENTS AND APPEARANCE

ACNE SOLUTIONS  CLINICAL CLEARING GEL
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-116
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WITCH HAZEL (UNII: 101I4J0U34)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-116-01	1 in 1 CARTON	12/21/2023
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49527-116-02	1 in 1 CARTON	12/21/2023
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 49527-116-03	1 in 1 CARTON	12/21/2023
3		3 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	12/21/2023

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder N.V.		370151326	manufacture(49527-116) , pack(49527-116) , label(49527-116)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(49527-116) , pack(49527-116) , label(49527-116)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	pack(49527-116) , label(49527-116)

Establishment
Name	Address	ID/FEI	Business Operations
Northtec LLC		943871157	pack(49527-116) , label(49527-116)

Establishment
Name	Address	ID/FEI	Business Operations
PALC		078364654	pack(49527-116) , label(49527-116)