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, glycerin • butylene glycol • sodium methyl cocoyl taurate • sucrose • disodium phosphate • arginine cocoate • laminaria saccharina extract• cola nitida (kola) seed extract • caffeine • algae extract • mentha piperita (peppermint) • sea whip extract • peg/ppg-18/18 dimethicone • sodium hyaluronate • ppg-6 decyltetradeceth-30 • lactobacillus ferment • stearamidopropyl dimethylamine • longifolene • acetyl glucosamine • capryloyl glycine • perilla aldehyde • 10-hydroxydecanoic acid • polyquaternium-7 • beta-caryophyllene • phospholipids • sodium stearate • sodium salicylate • disodium edta • phenoxyethanol • chloroxylenol [iln32337]

PRINCIPAL DISPLAY PANEL - 125 ml Bottle Label

C
CLINIQUE
acne solutions

cleansing foam

STEP 1
SALICYLIC ACID ACNE MEDICATION

4.2 FL.OZ./125 ml e

Principal Display Panel - 125 ml Bottle Label

ACNE SOLUTIONS CLEANSING FOAM
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49527-992
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)	salicylic acid	2 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
butylene glycol (UNII: 3XUS85K0RA)
sodium methyl cocoyl taurate (UNII: JVL98CG53G)
sucrose (UNII: C151H8M554)
saccharina latissima thallus (UNII: 68CMP2MB55)
cola nut (UNII: PQM9SA369U)
caffeine (UNII: 3G6A5W338E)
peppermint (UNII: V95R5KMY2B)
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)
hyaluronate sodium (UNII: YSE9PPT4TH)
stearamidopropyl dimethylamine (UNII: K7VEI00UFR)
N-acetylglucosamine (UNII: V956696549)
capryloyl glycine (UNII: 8TY5YO42NJ)
perillaldehyde (UNII: 6EQL0XA86G)
10-hydroxydecanoic acid (UNII: NP03XO416B)
caryophyllene (UNII: BHW853AU9H)
sodium stearate (UNII: QU7E2XA9TG)
sodium salicylate (UNII: WIQ1H85SYP)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
chloroxylenol (UNII: 0F32U78V2Q)

#	Item Code	Package Description
Packaging
1	NDC:49527-992-01	1 in 1 CARTON
1		125 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	12/12/2006

Labeler - CLINIQUE LABORATORIES INC (173047747)

Name	Address	ID/FEI	Business Operations
Establishment
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE, RELABEL, REPACK

Name	Address	ID/FEI	Business Operations
Establishment
ARAMIS, INC		042918826	MANUFACTURE

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK, RELABEL

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	MANUFACTURE

Name	Address	ID/FEI	Business Operations
Establishment
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE

Name	Address	ID/FEI	Business Operations
Establishment
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC BRISTOL		949264774	MANUFACTURE, RELABEL, REPACK

Name	Address	ID/FEI	Business Operations
Establishment
NORTHTEC KEYSTONE		618107429	MANUFACTURE, RELABEL, REPACK

Name	Address	ID/FEI	Business Operations
Establishment
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

Name	Address	ID/FEI	Business Operations
Establishment
Aveda Corporation		071352058	MANUFACTURE

CLINIQUE acne solutions