Label: ACNE SOLUTIONS CLEANSING BAR FOR FACE AND BODY- salicylic acid soap

  • NDC Code(s): 49527-999-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 5, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne treatment

  • Uses

    • treats acne
    • clears acne blemishes
    • helps prevent the development of new acne blemishes
  • 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

    • use hands to work into lather
    • massage gently over wet skin, avoiding eye area
    • rinse
    • use AM and PM
    • if bothersome drying or peeling occurs, reduce usage to every other day
    • after acne clears, continue using for preventative care
    • follow with Acne Solutions Clarifying Lotion
  • Inactive ingredients

    sodium palmate∙sodium cocoate∙water∙palmitic acid∙glycerin∙caffeine∙zinc pca∙ppg-26/dimer dilinoleate copolymer∙sodium chloride∙tetrasodium edta∙tetrasodium etidronate∙chlorphenesin∙titanium dioxide (ci 77891) [iln47557]

  • SPL UNCLASSIFIED SECTION

    © CLINIQUE LABORATORIES, DIST.
    NEW YORK, N.Y. 10022

  • PRINCIPAL DISPLAY PANEL - 150 g Carton

    acne

    CLINIQUE

    acne solutions

    cleansing bar
    for face and body

    STEP 1

    SALICYLIC ACID
    ACNE MEDICATION

    ALL SKIN TYPES

    NET WT. 5.2 OZ./150 g e

    Principal Display Panel - 150 g Carton
  • INGREDIENTS AND APPEARANCE
    ACNE SOLUTIONS  CLEANSING BAR FOR FACE AND BODY
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-999
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    WATER (UNII: 059QF0KO0R)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-999-01150 g in 1 CARTON; Type 0: Not a Combination Product04/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00604/01/2006
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture(49527-999) , pack(49527-999) , label(49527-999)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982manufacture(49527-999) , pack(49527-999) , label(49527-999)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture(49527-999) , pack(49527-999) , label(49527-999)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(49527-999) , pack(49527-999) , label(49527-999)
    Establishment
    NameAddressID/FEIBusiness Operations
    PALC078364654pack(49527-999) , label(49527-999)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(49527-999) , label(49527-999)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec LLC943871157pack(49527-999) , label(49527-999)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774pack(49527-999) , label(49527-999)