CLINIQUE ACNE SOLUTIONS CLEANSING FOAM- salicylic acid liquid

CLINIQUE ACNE SOLUTIONS CLEANSING FOAM by

Drug Labeling and Warnings

CLINIQUE ACNE SOLUTIONS CLEANSING FOAM by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Estee Lauder N.V., Whitman Laboratories Ltd., The Estee Lauder Inc, PADC 1, Northtec LLC, PALC, Estee Lauder Cosmetics Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

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

Warnings

For external use only

When using this product using 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• pump dispenser 2-3 times
• massage gently over wet skin, avoiding eye area
• rinse
• use AM and PM
• if bothersome drying or peeling occurs, reduce usage to every other day
• after acne clears, continue using for preventative care
• follow with Acne Solutions Clarifying Lotion

Inactive ingredients

water\aqua\eau glycerin butylene glycol sodium methyl cocoyl taurate sucrose disodium phosphate arginine cocoate laminaria saccharina extract caffeine algae extract cola acuminata (kola) seed extract sea whip extract peg/ppg-18/18 dimethicone sodium hyaluronate ppg-6-decyltetradeceth-30 lactobacillus ferment stearamidopropyl dimethylamine acetyl glucosamine capryloyl glycine 10-hydroxydecanoic acid polyquaternium-7 phospholipids stearic acid sodium hydroxide disodium edta phenoxyethanol chloroxylenol [iln41840]

PRINCIPAL DISPLAY PANEL - 125 ml Bottle Label

CLINIQUE

acne solutions

cleansing

foam

STEP 1

SALICYLIC ACID ACNE MEDICATION

4.2 FL.OZ.LIQ./125 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE ACNE SOLUTIONS CLEANSING FOAM 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SUCROSE (UNII: C151H8M554)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
ARGININE COCOATE (UNII: 951Q8XZ62H)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
CAFFEINE (UNII: 3G6A5W338E)
CARRAGEENAN (UNII: 5C69YCD2YJ)
COLA ACUMINATA SEED (UNII: 1F8VIW1479)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DECYLTETRADECETH-30 (UNII: 6FLU72F7LG)
LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-079-01	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020	11/23/2025
2	NDC: 49527-079-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/21/2020	11/23/2025

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
PALC		078364654	label(49527-079) , pack(49527-079)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(49527-079) , pack(49527-079) , label(49527-079)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC LLC		943871157	label(49527-079) , pack(49527-079)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	label(49527-079) , pack(49527-079)