Label: CONCEALING SPOT TREATMENT- sulfur 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 19, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sulfur (5.0%)

  • Purpose

    Acne treatment

  • Indications

    • For the treatment of acne.
  • Warnings

    For external use only

    Do not use

    • on broken skin.
    • on large areas of the body.

    Using other topical acne medications

    • at the same time or immediately following use of this product may increase dryness or or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    Stop use and ask a doctor

    • if excessive skin irritation develops or increases.

    Keep out of reach of children

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

    • Dot onto finger and apply to cleansed skin.
    • Let stand for five seconds, then pat until blended in.
    • Use 1-2 times daily until breakout has cleared.
  • Inactive ingredients

    Hamamelis Virginiana (Witch Hazel) Water, Ethyl Trisiloxane, Butylene Glycol, Silica Dimethyl Silylate, Cetearyl Alcohol, Peg-40 Hydrogenated Castor Oil, Dimethicone, Ceratonia Siliqua (Carob) Seed Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Cinnamomum Zeylanicum Bark Extract, Niacinamide, Yeast Extract, Salicylic Acid, Biotin, Zinc Gluconate, Panthenol, Montmorillonite, Caffeine, Lauryl PEG/PPG-18/18 Methicone, Camphor, Capryloyl Glycine, Sarcosine, Ammonium Glycyrrhizate, Ceteareth-20, Potassium Alum, Water, Xanthan Gum, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492), (CI 77491), (CI 77499), Titanium Dioxide (CI 77891), Zinc Oxide (CI 77947).

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton

    new
    improved
    formula

    concealing
    spot
    treatment

    acne treatment

    mediBac clearing®

    0.33 US FL OZ
    10 mL e

    dermalogica®

    PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    CONCEALING SPOT TREATMENT 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    ETHYL TRISILOXANE (UNII: ZH1WJO5481)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    BIOTIN (UNII: 6SO6U10H04)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MONTMORILLONITE (UNII: A585MN1H2L)  
    CAFFEINE (UNII: 3G6A5W338E)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    SARCOSINE (UNII: Z711V88R5F)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    POTASSIUM ALUM (UNII: 1L24V9R23S)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-005-021 in 1 CARTON
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-005-013 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:68479-005-002 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/22/2014
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab790530976MANUFACTURE(68479-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-005)
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