ACNE SOLUTIONS EMERGENCY

Dosage form: lotion
Ingredients: BENZOYL PEROXIDE 2.5mL in 100mL
Labeler: CLINIQUE LABORATORIES INC
NDC Code: 49527-718

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.

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:

  • 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

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







ACNE SOLUTIONS  EMERGENCY
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-718
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE2.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALKYL (C12-15) BENZOATE 
GLYCERIN 
CETOSTEARYL ALCOHOL 
STEARETH-2 
SUCROSE 
STEARETH-20 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
GREEN TEA LEAF 
CAFFEINE 
YEAST 
COLA NITIDA SEED 
PSEUDOPTEROGORGIA ELISABETHAE 
C13-14 ISOPARAFFIN 
BUTYLENE GLYCOL 
LAURETH-7 
CHLOROXYLENOL 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:49527-718-011 TUBE (TUBE) 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/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture
Establishment
NameAddressID/FEIOperations
CONTRACT PHARMACEUTICALS248761249manufacture

Revised: 07/2011
 
CLINIQUE LABORATORIES INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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