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Name:Acne Solutions Oil Control Cleansing Maskacne Medication All Skin Types
Manufacturer:Clinique Laboratories Inc
Category:Over-the-counter (OTC) Marketed Drugs


ACNE SOLUTIONS OIL CONTROL CLEANSING MASK ACNE MEDICATION ALL SKIN TYPES - salicylic acid cream 
CLINIQUE LABORATORIES INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT: 1.0% SALICYLIC ACID

PURPOSE: ACNE TREATMENT

USE: FOR THE TREATMENT OF ACNE

WARNING: 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 
  • APPLY EVENLY TO CLEAN SKIN, AVOIDING EYE AREA
  • LEAVE ON 5 MINUTES
  • RINSE THOROUGHLY WITH WARM WATER
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.

INACTIVE INGREDIENTS: WATER, KAOLIN, BUTYLENE GLYCOL, MAGNESIUM ALUMINUM SILICATE, SODIUM LAUROYL SARCOSINATE, GLYCERYL STEARATE, PEG-100 STEARATE, GENTIANA LUTEA (GENTIAN) ROOT EXTRACT, LAMINARIA SACCHARINA EXTRACT, SUCROSE, CHAMOMILLA RECUTITA (MATRICARIA), ALGAE EXTRACT, ALOE BARBADENSIS POWDER, ACETYL GLUCOSAMINE, INULIN, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, XANTHAN GUM, DISODIUM EDTA, CHLORPHENESIN, PHENOXYETHANOL, TITANIUM DIOXIDE  ILN34859

PRINCIPAL DISPLAY PANEL   3.4 FL OZ/ 100 mL CARTON


CLINIQUE ACNE SOLUTIONS
OIL- CONTROL CLEANSING MASK  
SALICYLIC ACID
ACNE MEDICATION

ALL SKIN TYPES


3.4 FL OZ/ 100 mL


CLINIQUE LABORATORIES, DIST.
NEW YORK, NY 10022

CLINIQUE.COM
68G5
FOLDING CARTON




ACNE SOLUTIONS OIL CONTROL CLEANSING MASK  ACNE MEDICATION ALL SKIN TYPES
salicylic acid cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-713
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID ) SALICYLIC ACID 1.0 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49527-713-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE (49527-713-02)
1 NDC:49527-713-02 100 mL in 1 TUBE This package is contained within the CARTON (49527-713-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 09/01/2007

Labeler - CLINIQUE LABORATORIES INC (173047747)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER N.V. 370151326 manufacture
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
Establishment
Name Address ID/FEI Operations
Aramis Inc. 042918826 manufacture
Establishment
Name Address ID/FEI Operations
Northtec Bristol 949264774 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Northtec Keystone 618107429 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
PADC 1 110482184 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd. 255175580 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd 253616536 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Distribution Center 208579636 manufacture, label, relabel
Establishment
Name Address ID/FEI Operations
Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture
Establishment
Name Address ID/FEI Operations
Aveda Corporation 071352058 manufacture

Revised: 04/2010 CLINIQUE LABORATORIES INC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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