Label: POWERSPOT CLEANSE- sulfur soap

  • 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 14, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Sulfur 3%

  • Purpose

    Acne treatment

  • Uses

    • For the treatment of acne
    • Helps keep skin clear of new acne blemishes
  • Warnings

    For external use only.

    • Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.
    • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Gently lather a small amount of cleanser in moistened hands and apply to face and neck. Rinse with warm water.
  • Inactive Ingredients

    Water (Aqua), Sodium Cocoyl Isethionate, Cetearyl Alcohol, Coco-Glucoside, Colloidal Sulfur, Isoamyl Laurate, Coconut Alcohol, Xanthan Gum, Salicylic Acid, Glycolic Acid, Camphor, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Curcuma Longa (Tumeric) Root Extract, Ocimum Basilicum (Basil) Extract, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Extract, Melia Azadirachta Flower Extract, Lawsonia Inermis (Henna) Extract, Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant) Fruit Extract, Melia Azadirachta Leaf Extract, Ocimum Sanctum Leaf Extract, Amino Esters-1, Glycerin, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Acrylates Copolymer, Malachite Extract, Mica, Pearl Powder

  • PRINCIPAL DISPLAY PANEL - 120 mL Tube Carton

    m-61®
    powerful skincare

    PowerSpot
    Cleanse

    CLARIFYING
    3% SULFUR
    ACNE TREATMENT
    FACE CLEANSER

    Blemish-fighting
    and clarifying
    foaming cleanser
    with salicylic acid,
    tea tree & cucumber

    combination / blemish-prone skin

    100% paraben-free
    100% synthetic fragrance-free
    dermatologist tested
    allergy tested

    120 mL e 4 FL. OZ.

    Principal Display Panel - 120 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    POWERSPOT CLEANSE 
    sulfur soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72203-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TURMERIC (UNII: 856YO1Z64F)  
    BASIL (UNII: 2U0KZP0FDW)  
    RICE BRAN (UNII: R60QEP13IC)  
    OAT (UNII: Z6J799EAJK)  
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    LAWSONIA INERMIS LEAF (UNII: E5818YZ355)  
    COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
    EGGPLANT (UNII: W5K7RAS4VK)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    HOLY BASIL LEAF (UNII: SCJ765569P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    MICA (UNII: V8A1AW0880)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72203-014-011 in 1 CARTON03/15/2019
    1120 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:72203-014-021 in 1 CARTON03/15/2019
    250 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D03/15/2019
    Labeler - Bluemercury (097435361)
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