Label: BREAKOUT CLEARING ALL OVER TONER- salicylic acid liquid

  • 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 February 5, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid (1.0%)

  • Purpose

    Acne Treatment

  • Use

    • For the treatment of acne
  • Warnings

    For external use only

    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 usage to one topical 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.
    • Keep eyes closed.
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Isoceteth-20, Ethoxydiglycol, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Camellia Sinensis Leaf Extract, Porphyra Umbilicalis Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Citrus Aurantium Amara (Bitter Orange) Peel Oil, Citrus Limon (Lemon) Fruit Oil, Cymbopogon Schoenanthus Oil, Argania Spinosa Kernel Extract, Serenoa Serrulata Fruit Extract, Sesamum Indicum (Sesame) Seed Extract, Citral, Hexylene Glycol, Geraniol, Limonene, Polysorbate 20, Disodium EDTA, Butylene Glycol, Linalool, Ethylhexylglycerin, Phenoxyethanol.

  • Questions or comments

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

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    dermalogica®
    clear

    1%
    salicylic
    acid

    Breakout Clearing
    All Over
    Toner

    4.0 US FL OZ / 118 mL e

    Principal Display Panel - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BREAKOUT CLEARING ALL OVER TONER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-312
    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)  
    Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)  
    Isoceteth-20 (UNII: O020065R7Z)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Orange Oil (UNII: AKN3KSD11B)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Porphyra Umbilicalis (UNII: 14AN0J70WO)  
    .Beta.-Sitosterol (UNII: S347WMO6M4)  
    Glycyrrhiza Glabra (UNII: 2788Z9758H)  
    Bitter Orange Oil (UNII: 9TLV70SV6I)  
    Citrus Limon Fruit Oil (UNII: 0HNC1J1YED)  
    Cymbopogon Schoenanthus Oil (UNII: XE7K568ILO)  
    Argania Spinosa Seed (UNII: 8H7X7XB54H)  
    Saw Palmetto (UNII: J7WWH9M8QS)  
    Sesame Seed (UNII: 7Y1255HVXR)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-312-021 in 1 CARTON
    1118 mL in 1 BOTTLE
    2NDC:68479-312-0150 mL in 1 BOTTLE
    3NDC:68479-312-002 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H09/05/2013
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway620899877MANUFACTURE(68479-312)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-312)
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