Label: OVERNIGHT CLEARING- salicylic acid gel

  • NDC Code(s): 68479-706-00, 68479-706-01, 68479-706-02
  • Packager: Dermalogica, Inc.
  • 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 December 4, 2017

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


    Drug Facts

  • Active Ingredients

    Salicylic Acid 2.0%

  • Indications

    • For the treatment of acne.
  • Warnings

    For external use only.

    Do not use on broken skin or on large areas of the body.

    When using this product

    • Apply to affected areas only
    • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

    Avoid unnecessary sun exposure and use a sunscreen.

    Do not use in or near eyes.

    Stop use and ask a Doctor if rash occurs.

    Keep out of reach of children.

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

  • Directions

    • Clean the skin thoroughly before applying.
    • Cover the affected area with a thin layer at night.
    • Because too much drying of the skin may occur, start with 1 application daily at night, and if bothersome dryness or peeling occurs, reduce application to 2 to 3 times per week.
  • Inactive ingredients

    Water (Aqua), PEG-32, Butylene Glycol, Salicylic Acid, PVM/MA Decadiene Crosspolymer, Polysorbate 20, Glycerin, PEG-60 Almond Glycerides, Mahonia Aquifolium Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Camellia Oleifera Leaf Extract, Spiraea Ulmaria Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Crithmum Maritimum Extract, Yeast Extract, Hydrogenated Vegetable Oil, Sodium Hyaluronate, Biotin, Panthenol, Caffeine, Niacinamide, Dipotassium Glycyrrhizate, Camphor, 10-Hydroxydecanoic Acid, Sebacic Acid, 1,10-Decanediol, Nordihydroquaiaretic Acid, Oleanolic Acid, Xanthan Gum, Carbomer, PEG-40 Hydrogenated Castor Oil, Ammonium Glycyrrhizate, Zinc Gluconate, Zinc Acetate, Sodium Hydroxide, Caprylic/Capric Triglyceride, Chlorphenesin, Caprylyl Glycol, Phenoxyethanol, Limonene, Linalool, Geraniol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Cymbopogon Martini Oil, Mentha Piperita (Peppermint) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Mentha Viridis (Spearmint) Leaf Oil, Pelargonium Graveolens Flower Oil, Eucalyptus Globulus Leaf Oil, Zingiber Officinale (Ginger) Root Oil, Artemisia Vulgaris Oil, Litsea Cubeba Fruit Oil, Piper Nigrum (Pepper) Seed Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Ocimum Basilicum (Basil) Oil, Cymbopogon Nardus (Citronella) Oil, Cinnamomum Zeylanicum Bark Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Salvia Officinalis (Sage) Oil, Thymus Vulgaris (Thyme) Oil.

  • Questions or comments

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

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton


    acne treatment

    mediBac clearing®

    1.7 US FL OZ
    50 mL e


    Principal Display Panel - 50 mL Bottle Carton
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-706
    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
    Water (UNII: 059QF0KO0R)  
    Polyethylene Glycol 1500 (UNII: 1212Z7S33A)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Glycerin (UNII: PDC6A3C0OX)  
    PEG-60 Almond Glycerides (UNII: 4Y0E651N0F)  
    Rosemary (UNII: IJ67X351P9)  
    Camellia Oleifera Leaf (UNII: 5077EL0C60)  
    Filipendula Ulmaria Root (UNII: 997724QNDS)  
    Horse Chestnut (UNII: 3C18L6RJAZ)  
    Crithmum Maritimum (UNII: J7IHY79BKY)  
    Yeast, Unspecified (UNII: 3NY3SM6B8U)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Biotin (UNII: 6SO6U10H04)  
    Panthenol (UNII: WV9CM0O67Z)  
    Caffeine (UNII: 3G6A5W338E)  
    Niacinamide (UNII: 25X51I8RD4)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Camphor (Synthetic) (UNII: 5TJD82A1ET)  
    10-Hydroxydecanoic Acid (UNII: NP03XO416B)  
    Sebacic Acid (UNII: 97AN39ICTC)  
    1,10-Decanediol (UNII: 5I577UDK52)  
    Masoprocol (UNII: 7BO8G1BYQU)  
    Oleanolic Acid (UNII: 6SMK8R7TGJ)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)  
    Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
    Zinc Gluconate (UNII: U6WSN5SQ1Z)  
    Zinc Acetate (UNII: FM5526K07A)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Rosemary Oil (UNII: 8LGU7VM393)  
    Palmarosa Oil (UNII: 0J3G3O53ST)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
    Lemon Oil (UNII: I9GRO824LL)  
    Fennel Oil (UNII: 59AAO5F6HT)  
    Spearmint Oil (UNII: C3M81465G5)  
    Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Ginger Oil (UNII: SAS9Z1SVUK)  
    Artemisia Vulgaris Top Oil (UNII: 72Q967Y48V)  
    Litsea Oil (UNII: 2XIW34BN6O)  
    White Pepper Oil (UNII: 2AM83DL9FV)  
    Nutmeg Oil (UNII: Z1CLM48948)  
    Basil Oil (UNII: Z129UMU8LE)  
    Citronella Oil (UNII: QYO8Q067D0)  
    Cinnamon Bark Oil (UNII: XE54U569EC)  
    Orange Oil (UNII: AKN3KSD11B)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Sage Oil (UNII: U27K0H1H2O)  
    Thyme Oil (UNII: 2UK410MY6B)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-706-021 in 1 CARTON05/01/2007
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68479-706-0114 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2007
    3NDC:68479-706-002 mL in 1 POUCH; Type 0: Not a Combination Product05/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H05/01/2007
    Labeler - Dermalogica, Inc. (177698560)
    NameAddressID/FEIBusiness Operations
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-706)