Label: CLEARING SKIN WASH- 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 November 19, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid (0.5%).

  • PURPOSE

    Indications

    • For the treatment of 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 acne products at the same time, limit usage to one acne product.

    Keep out of reach of children.

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

  • Directions

    • Work a pea-sized amount into a lather in wet hands.
    • Apply to dampened face and throat, massaging in circular motions while concentrating on areas of congestion and oiliness.
    • Avoid eye area.
    • Rinse thoroughly with warm water.
    • Follow with Skin Purifying Wipes and prescribed MediBac Clearing® regimen.
  • Inactive ingredients

    Water/Aqua/Eau, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Sodium Lauroyl Methyl Isethionate, Melissa Officinalis Leaf Extract, Angelica Archangelica Extract, Echinacea Angustifolia Extract, Allium Sativum (Garlic) Bulb Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Extract, Salvia Officinalis (Sage) Extract, Passiflora Incarnata Extract, Citrus Medica Limonum (Lemon) Peel Extract, Hamamelis Virginiana (Witch Hazel) Extract, Ophiopogon Japonicas Root Extract, Echinacea Purpurea Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lactic Acid, Algae Extract, Menthol, Sodium PCA, Dipotassium Glycyrrhizate, Camphor, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Butylene Glycol, Benzyl PCA, Disodium EDTA Copper, Citral, Limonene, Geraniol, Citronellol.

  • Questions or comments

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

  • PRINCIPAL DISPLAY PANEL - 250 mL Bottle Carton

    clearing
    skin
    wash

    acne treatment

    mediBac clearing®

    8.4 US FL OZ
    250 mL e

    dermalogica®

    Principal Display Panel - 250 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CLEARING SKIN WASH 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)  
    Sodium Lauroyl Methyl Isethionate (UNII: II6VCD3S6R)  
    Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
    Angelica Archangelica Root (UNII: DTN01M69SN)  
    Echinacea Angustifolia (UNII: VB06AV5US8)  
    Garlic (UNII: V1V998DC17)  
    Chamomile (UNII: FGL3685T2X)  
    Eucalyptus Globulus Leaf (UNII: S546YLW6E6)  
    Salvia Officinalis Root (UNII: 236QY0A1BL)  
    Lemon Peel (UNII: 72O054U628)  
    Hamamelis Virginiana Top (UNII: UDA30A2JJY)  
    Ophiopogon Japonicus Root (UNII: 90PS6JV9GZ)  
    Echinacea Purpurea (UNII: QI7G114Y98)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Camphor (Synthetic) (UNII: 5TJD82A1ET)  
    PEG-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Benzyl PCA (UNII: OUS14HJ3HZ)  
    Disodium EDTA-Copper (UNII: 6V475AX06U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-040-021 in 1 CARTON
    1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:68479-040-002 mL in 1 POUCH; Type 0: Not a Combination Product
    3NDC:68479-040-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:68479-040-017 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:68479-040-04946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H12/30/2009
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway620899877MANUFACTURE(68479-040)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-040)
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