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Name:Acne Solutions Clearing Moisturizer Acne Medication
Manufacturer:Clinique Laboratories Inc
Category:Over-the-counter (OTC) Marketed Drugs


ACNE SOLUTIONS  CLEARING MOISTURIZER ACNE MEDICATION - benzoyl peroxide lotion 
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: BENZOYL PEROXIDE 2.5%

INACTIVE INGREDIENTS: water [] cyclopentasiloxane [] butylene glycol [] ceteareth-20 [] dimethicone [] sucrose [] camellia sinensis (green tea) leaf extract [] hordeum vulgare (barley) extract\extrait d'orge [] acetyl glucosamine [] lactobacillus ferment [] poria cocos sclerotium extract [] laminaria saccharina extract [] polymethyl methacrylate [] gentiana lutea (gentian) root extract [] helianthus annuus (sunflower) seedcake [] saccharomyces lysate extract [] astrocaryum murumuru butter [] acrylamide/sodium acryloyldimethyltaurate copolymer [] myristyl alcohol [] glycerin [] zeolite [] algae extract [] linoleic acid [] 10-hydroxydecanoic acid [] cucumis sativus (cucumber) fruit extract [] caffeine [] cholesterol [] tocopheryl acetate [] bisabolol [] longifolene [] polysorbate 80 [] sodium hyaluronate [] beta-caryophyllene [] propylene glycol dicaprate [] capryloyl glycine [] quaternium-22 [] mentha piperita (peppermint) [] perilla aldehyde [] caprylyl glycol [] isohexadecane [] xanthan gum [] disodium edta [] chloroxylenol [] phenoxyethanol [] titanium dioxide (ci 77891)

USES:

  • TREATS ACNE
  • CLEARS ACNE BLEMISHES
  • HELPS PREVENT DEVELOPMENT OF NEW ACNE BLEMISHES

WARNING: FOR EXTERNAL USE ONLY

DO NOT USE IF YOU

  • HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE

WHEN USING THIS PRODUCT

  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THIS TIME. IF IRRITATION OCCURS, USE ONLY ONE TOPICAL ACNE MEDICATION AT AT TIME
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
  • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH
  • AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT
  • SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION

STOP USE AND ASK A DOCTOR IF

  • IRRITATION BECOMES SEVERE

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MECICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS:

  • CLEANS SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT
  • COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY
  • BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DOY OR EVERY OTHER DAY
  • IF GOING OUTSIDE, USE A SUNSCREEN AFTER APPLYING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR
  • FOR BEST RESULTS, USE AFTER ACNE SOLUTIONS CLEANSING FOAM AND CLARIFYING LOTION

 COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY

CLINIQUE

ACNE SOLUTIONS

CLEARING MOISTURIZER

OIL FREE

BENZOYL PEROXIDE

ACNE MEDICATION

FOR ALL SKIN TYPES



1.7 FL. OZ.LIQ./50 ML


CLINIQUE LABORATORIES DIST

NEW YORK, NY 10022



FOLDING CARTON



ACNE SOLUTIONS   CLEARING MOISTURIZER ACNE MEDICATION
benzoyl peroxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-997
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.5 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL  
DIMETHICONE  
ASTROCARYUM MURUMURU SEED BUTTER  
GLYCERIN  
CHOLESTEROL  
XANTHAN GUM  
CYCLOMETHICONE 5  
SUCROSE  
BARLEY  
GLUCOSAMINE  
LAMINARIA SACCHARINA  
GENTIANA LUTEA ROOT  
SACCHAROMYCES LYSATE  
MYRISTYL ALCOHOL  
LINOLEIC ACID  
CUCUMBER  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
HYALURONATE SODIUM  
CAPRYLYL GLYCOL  
EDETATE DISODIUM  
PHENOXYETHANOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49527-997-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE (49527-997-02)
1 NDC:49527-997-02 50 mL in 1 TUBE This package is contained within the CARTON (49527-997-01)

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 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
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 repack, 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
Establishment
Name Address ID/FEI Operations
HARMONY LABS INC 105803274 manufacture

Revised: 05/2011 CLINIQUE LABORATORIES INC



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


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