Label: OIL CONTROL- 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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid (1.0%)

  • 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. Consult a doctor if irritation persists.

    When using this product

    • If dryness or irritation occurs when using other topical 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

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

    Water/Aqua/Eau, Butylene Glycol, C12-15 Alkyl Benzoate, Isododecane, Potato Starch Modified, Silica, Hyssopus Officinalis Extract, Melissa Officinalis Leaf Extract, Echinacea Purpurea Extract, Enantia Chlorantha Bark Extract, Yeast Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Salix Nigra (Willow) Bark Extract, Allantoin, Panthenol, Sodium PCA, Bisabolol, Niacinamide, Ammonium Glycyrrhizate, Zinc Gluconate, Caffeine, Biotin, Phospholipids, Magnesium Ascorbyl Phosphate, Camphor, Menthol, Hamamelis Virginiana (Witch Hazel) Water, Oleanolic Acid, Sodium Hydroxide, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Xanthan Gum, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Nylon-12, Glycerin, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

  • Questions or comments

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

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    oil
    control
    lotion

    dermalogica®

    mediBac clearing®

    2 US FL OZ
    60 mL e

    Principal Display Panel - 60 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    OIL CONTROL 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-808
    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)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Isododecane (UNII: A8289P68Y2)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Hyssopus Officinalis Flowering Top (UNII: X7HKN4FOJI)  
    Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
    Echinacea Purpurea (UNII: QI7G114Y98)  
    Annickia Chlorantha Bark (UNII: H70115MP4A)  
    Yeast, Unspecified (UNII: 3NY3SM6B8U)  
    Horse Chestnut (UNII: 3C18L6RJAZ)  
    Allantoin (UNII: 344S277G0Z)  
    Panthenol (UNII: WV9CM0O67Z)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Levomenol (UNII: 24WE03BX2T)  
    Omega-3 Fatty Acids (UNII: 71M78END5S)  
    Niacinamide (UNII: 25X51I8RD4)  
    Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
    Zinc Gluconate (UNII: U6WSN5SQ1Z)  
    Caffeine (UNII: 3G6A5W338E)  
    Biotin (UNII: 6SO6U10H04)  
    Oleanolic Acid (UNII: 6SMK8R7TGJ)  
    Salix Nigra Bark (UNII: QU52J3A5B3)  
    Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
    Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Nylon-12 (UNII: 446U8J075B)  
    Camphor (Synthetic) (UNII: 5TJD82A1ET)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-808-021 in 1 CARTON
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68479-808-0122 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68479-808-04177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:68479-808-002 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H12/04/2003
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway620899877MANUFACTURE(68479-808)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-808)
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