ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION

Dosage form: gel
Ingredients: SALICYLIC ACID 0.5mL in 100mL
Labeler: CLINIQUE LABORATORIES INC
NDC Code: 49527-825

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:    SALICYLIC ACID 0.5%

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: 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
  • 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 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:


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

ACNE SOLUTIONS  SPOT HEALING ACNE MEDICATION
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-825
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
WATER 
WITCH HAZEL 
PSEUDOPTEROGORGIA ELISABETHAE 
BUTYLENE GLYCOL 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:49527-825-011 TUBE (TUBE) in 1 CARTON
1NDC:49527-825-0215 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/01/2008
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

Revised: 06/2011
 
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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