ACNE SOLUTIONS EMERGENCY- 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 0.5%

water [] c12-15 alkyl benzoate [] glycerin [] cetearyl alcohol [] steareth-2 [] sucrose [] steareth-20 [] polyacrylamide [] dimethicone [] glyceryl stearate [] peg-100 stearate [] acetyl glucosamine [] camellia sinensis leaf extract [] caffeine [] yeast extract (faex) [] cola nitida extract [] laminaria saccharina extract [] sea whip extract [] c13-14 isoparaffin [] butylene glycol [] laureth-7 [] chloroxylenol [] phenoxyethanol

USES:

WARNING: FOR EXTERNAL USE ONLY

DO NOT USE IF YOU

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS:

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

PRINCIPAL DISPLAY PANEL:

CLINIQUE

ACNE SOLUTIONS

EMERGENCY

GEL-LOTION

BENZOYL PEROXIDE

ACNE MEDICATION

ALL SKIN TYPES



0.5 FL OZ LIQ. / 15 ML




CLINIQUE LABORATORIES DIST
NEW YORK, NEW YORK 10022

FOLDING CARTON






ACNE SOLUTIONS  EMERGENCY
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-718
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARETH-2 (UNII: V56DFE46J5)  
SUCROSE (UNII: C151H8M554)  
STEARETH-20 (UNII: L0Q8IK9E08)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAFFEINE (UNII: 3G6A5W338E)  
YEAST (UNII: 3NY3SM6B8U)  
COLA NITIDA SEED (UNII: PQM9SA369U)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LAURETH-7 (UNII: Z95S6G8201)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-718-011 in 1 CARTON
1NDC:49527-718-0215 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/01/2000
Labeler - CLINIQUE LABORATORIES INC (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture
Establishment
NameAddressID/FEIBusiness Operations
CONTRACT PHARMACEUTICALS248761249manufacture

Revised: 7/2011
Document Id: 8becbebb-d1e3-45aa-8a1f-43d5de0afc99
Set id: aa1e44ec-653f-4d17-a165-fc9aeecb2d86
Version: 2
Effective Time: 20110721
 
CLINIQUE LABORATORIES INC