Label: BLACKHEAD SOLUTIONS 7 DAY DEEP PORE CLEANSE AND SCRUB ACNE MEDICATION- salicylic acid cream

  • NDC Code(s): 49527-062-01, 49527-062-02
  • 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 January 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 1.0%

  • Purpose

    Acne Treatment

  • Uses

    • reduces the number of blackheads
    • helps keep skin clear of new blackheads
    • helps prevent development of new blackheads
  • Warnings

    For external use only

    When using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only one topical acne medication should be used unless directed by a doctor.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of eyes.

  • Directions

    • Apply to face daily, wet and massage, rinse off.
  • Inactive ingredients

    water\aqua\eau • kaolin • glycerin • butylene glycol • magnesium aluminum silicate • glyceryl stearate • peg-100 stearate • silica • sodium lauroyl sarcosinate • allyl methacrylates crosspolymer • gentiana lutea (gentian) root extract • laminaria saccharina extract • sucrose • acetyl glucosamine • caprylyl glycol • 1,2-hexanediol • tocopheryl acetate • sodium hydroxide • xanthan gum • disodium edta • phenoxyethanol • titanium dioxide (ci 77891) • blue 1 (ci 42090) • yellow 5 (ci 19140) [iln43442]

  • PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

    CLINIQUE

    blackhead
    solutions

    7 day deep pore
    cleanse & scrub

    SALICYLIC ACID
    ACNE MEDICATION

    ALL SKIN TYPES

    .5 FL.OZ.LIQ./15 ml e

    PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BLACKHEAD SOLUTIONS 7 DAY DEEP PORE CLEANSE AND SCRUB ACNE MEDICATION 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SUCROSE (UNII: C151H8M554)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-062-011 in 1 CARTON08/30/201811/30/2022
    120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49527-062-021 in 1 CARTON08/01/2022
    2125 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00608/30/2018
    Labeler - CLINIQUE LABORATORIES LLC (044475127)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    PALC078364654pack(49527-062) , label(49527-062)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(49527-062) , label(49527-062)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(49527-062) , pack(49527-062) , label(49527-062)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436manufacture(49527-062) , pack(49527-062) , label(49527-062)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec LLC943871157pack(49527-062) , label(49527-062)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774pack(49527-062) , label(49527-062)
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