ACNE SOLUTIONS CLARIFYING- salicylic acid liquid

ACNE solutions CLARIFYING by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid 1.5%

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

• shake vigorously until powders dissolve
• using a cotton ball, sweep over face and throat, avoiding eye area
• use AM and PM after Acne Solutions Cleansing Foam
• if bothersome drying or peeling occurs, reduce usage to every other day
• after acne clears, continue using for preventative care
• follow with Acne Solutions Clearing Moisturizer

Other information

CAUTION: Flammable until dry. Do not use near heat or flame.

Inactive ingredients

water alcohol denat. nylon-12 butylene glycol hamamelis virginiana (witch hazel) laminaria saccharina extract caffeine sucrose glycerin acetyl glucosamine sorbitol sea whip extract barium sulfate 10-hydroxydecanoic acid silica disodium edta benzalkonium chloride [iln32340]

SPL UNCLASSIFIED SECTION

DIST. N.Y., N.Y. 10022
NEW YORK LONDON W1K 3BQ PARIS

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Carton

CLINIQUE

acne solutions

clarifying lotion

STEP 2
SALICYLIC ACID ACNE MEDICATION

6.7 FL.OZ./200 ml e

INGREDIENTS AND APPEARANCE

ACNE SOLUTIONS CLARIFYING 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-723
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NYLON-12 (UNII: 446U8J075B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
CAFFEINE (UNII: 3G6A5W338E)
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
SORBITOL (UNII: 506T60A25R)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
BARIUM SULFATE (UNII: 25BB7EKE2E)
10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-723-01	1 in 1 CARTON	09/01/2006
1		200 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	09/01/2006

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-723)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-723)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-723)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-723) , REPACK(49527-723)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-723)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-723) , REPACK(49527-723)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-723)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		202952982	MANUFACTURE(49527-723)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-723) , REPACK(49527-723)