Label: BLACKHEAD SOLUTIONS SELF-HEATING BLACKHEAD EXTRACTOR ACNE MEDICATION- salicylic acid cream

  • NDC Code(s): 49527-061-01
  • Packager: CLINIQUE LABORATORIES LLC
  • Category: HUMAN OTC DRUG LABEL

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 is 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

    • Use 3 times a week on clean, dry skin.
    • Unscrew top to dispense product.
    • Apply thin layer on blackhead-prone areas.
    • Reattach top.
    • Wet product on skin to activate heat.
    • Massage 15-30 seconds with applicator tip, then rinse.
  • Inactive ingredients

    magnesium sulfate • dimethicone • isononyl isononanoate • isododecane • polysilicone-11 • phenyl trimethicone • hydrogenated lecithin • acetyl glucosamine • polysorbate 20 • polysorbate 80 • polyethylene • diatomaceous earth\solum diatomeae\terre de diatomées • triethylhexanoin • pumice • bambusa arundinacea (bamboo) stem extract • peg-15/lauryl dimethicone crosspolymer • caprylyl glycol • stearyl glycyrrhetinate • water\aqua\eau • silica [iln43644]

  • PRINCIPAL DISPLAY PANEL - 20 ml Tube Carton

    blackheads

    CLINIQUE

    blackhead

    solutions

    self-heating

    blackhead

    extractor

    SALICYLIC ACID

    ACNE MEDICATION

    ALL SKIN TYPES

    .68 FL.OZ.LIQ./20 ml e

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    BLACKHEAD SOLUTIONS SELF-HEATING BLACKHEAD EXTRACTOR ACNE MEDICATION 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-061
    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
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    PUMICE (UNII: NT5NN5KL16)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-061-011 in 1 CARTON08/30/2018
    120 mL in 1 TUBE, WITH APPLICATOR; 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(49527-061) , label(49527-061)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062pack(49527-061) , label(49527-061)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(49527-061) , pack(49527-061) , label(49527-061)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Estee Lauder Inc802599436pack(49527-061) , label(49527-061) , manufacture(49527-061)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec LLC943871157pack(49527-061) , label(49527-061)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774pack(49527-061) , label(49527-061)
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