ACNE SOLUTIONS- salicylic acid liquid

ACNE SOLUTIONS by

Drug Labeling and Warnings

ACNE SOLUTIONS by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC, ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. 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, 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]

SPL UNCLASSIFIED SECTION

© CLINIQUE LABORATORIES, DIST. N.Y., N.Y. 10022

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

INGREDIENTS AND APPEARANCE

ACNE SOLUTIONS   CLEANSING FOAM
salicylic acid liquid

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

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

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

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

Labeler - CLINIQUE LABORATORIES INC (173047747)

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

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

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

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

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

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

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

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

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

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

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

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

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

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