Label: CLEARING MATTIFIER- salicylic acid lotion

  • 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 November 20, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid (2.0%)

  • Purpose

    Acne treatment

  • Use

    • Treats acne
  • Warnings

    For external use only

    Do not use

    • Do not use around eye area.
    • If contact occurs, flush thoroughly with water.
    • If irritation develops, discontinue use.

    When using this product

    • If dryness or irritation occurs when using other topical acne products at the same time, limit use to one acne product.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply to cleansed face and throat twice daily.
    • Avoid eye area.
  • Inactive ingredients

    Cyclopentasiloxane, Dimethicone Crosspolymer, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Ethoxydiglycol, Cetyl Ethylhexanoate, Enantia Chlorantha Bark Extract, Cinnamomum Zeylanicum Bark Extract, Oleanolic Acid, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Camellia Oleifera Leaf Extract, Corallina Officinalis Extract, Chamomilla Recutita (Matricaria) Flower Extract, Vitis Vinifera (Grape) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Niacinamide, Yeast Extract, Zinc Gluconate, Caffeine, Biotin, Ammonium Glycyrrhizate, Stearyl Glycyrrhetinate, Sarcosine, Tocopheryl Acetate, Retinyl Palmitate, Panthenol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PTFE, Capryloyl Glycine, Butylene Glycol, Propylene Glycol, Water/Aqua/Eau.

  • Questions or comments

    Call toll free 1-800-831-5150 in the US

  • PRINCIPAL DISPLAY PANEL - 40 mL Tube Carton

    clearing
    mattifier

    acne treatment

    mediBac clearing®

    1.3 US FL OZ / 40 mL e

    dermalogica®

    Principal Display Panel - 40 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLEARING MATTIFIER 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Cetyl Ethylhexanoate (UNII: 134647WMX4)  
    Water (UNII: 059QF0KO0R)  
    Annickia Chlorantha Bark (UNII: H70115MP4A)  
    Cinnamon Bark Oil (UNII: XE54U569EC)  
    Oleanolic Acid (UNII: 6SMK8R7TGJ)  
    Horse Chestnut (UNII: 3C18L6RJAZ)  
    Camellia Oleifera Leaf (UNII: 5077EL0C60)  
    Corallina Officinalis (UNII: 4004498D06)  
    Chamomile (UNII: FGL3685T2X)  
    Grape Seed Oil (UNII: 930MLC8XGG)  
    Safflower Oil (UNII: 65UEH262IS)  
    Niacinamide (UNII: 25X51I8RD4)  
    Yeast, Unspecified (UNII: 3NY3SM6B8U)  
    Zinc Gluconate (UNII: U6WSN5SQ1Z)  
    Caffeine (UNII: 3G6A5W338E)  
    Biotin (UNII: 6SO6U10H04)  
    Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
    Stearyl Glycyrrhetinate (UNII: 3YYE6VJS0P)  
    Sarcosine (UNII: Z711V88R5F)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Panthenol (UNII: WV9CM0O67Z)  
    Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    Capryloyl Glycine (UNII: 8TY5YO42NJ)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-411-021 in 1 CARTON
    140 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-411-0114 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:68479-411-002 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H04/17/2009
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway620899877MANUFACTURE(68479-411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-411)