ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION- 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., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, PADC 1, Northtec LLC, Estee Lauder Cosmetics Ltd., PALC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:    SALICYLIC ACID 0.5%

PURPOSE

PURPOSE:  ACNE TREATMENT

USE:  FOR THE TREATMENT OF ACNE

CLEARS UP ACNE BLEMISHES AND ALLOWS SKIN TO HEAL

HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES

INDICATIONS: FOR THE TREATMENT OF ACNE

WARNINGS

WARNINGS: FOR EXTERNAL USE ONLY. 

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

DIRECTIONS

• CLEANSE SKIN THOROUGHLY BEFORE APPLYING
• COVER THE ENTIRE AFFECTED AREA WITH ONE APPLICATION
• GRADUALLY INCREASE TO 2 OR 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
• IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.

INACTIVE INGREDIENT

inactive ingredients: alcohol denat. [] water\aqua\eau [] acrylates/c10-30 alkyl acrylate crosspolymer [] hamamelis virginiana (witch hazel) [] laminaria saccharina extract [] sea whip extract [] butylene glycol [] benzalkonium chloride

PRINCIPAL DISPLAY PANEL

principal display panel:

clinique

ACNE SOLUTIONS

SPOT HEALING GEL

SALICYLIC ACID

ACNE MEDICATION

ALL SKIN TYPES


0.5 FL.OZ LIQ./50 ML

CLINIQUE LABORATORIES INC, DISTR

NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

ACNE SOLUTIONS  SPOT HEALING ACNE MEDICATION
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-825
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
WITCH HAZEL (UNII: 101I4J0U34)
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: 49527-825-01	1 in 1 CARTON
1	NDC: 49527-825-02	15 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2008

Labeler - CLINIQUE LABORATORIES INC (173047747)

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
Aramis Inc.		042918826	manufacture

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
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	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 Kabushiki Kaisha		712808195	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