Label: KATE SUMMERVILLE ERADIKATE- sulfur cream

  • NDC Code(s): 11090-263-02
  • Packager: Beauty Manufacturing Solutions Corp.
  • Category: HUMAN OTC DRUG LABEL

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 11, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Sulfur 3.0%

    Purpose: Anti-Acne active ingredient

  • PURPOSE

    Acne Treatment

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only.

  • WHEN USING

    Skin irritation or dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

  • STOP USE

    if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    • AM and PM. Use twice a day. Apply a small amount to wet face and massage gently for 30 seconds. Rinse and gently pat dry. Avoid contact with eye area. Follow with EradiKate Acne Treatment for maximum results.
    • Because of excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • INACTIVE INGREDIENT

    Aqua/Water/Eau, Sodium Cocoyl Isethionate, Coco-Glucoside, Acrylates Copolymer, Coconut Alcohol, Glycereth-18 Ethylhexanoate, Glycereth-18, Stearyl Alcohol, Honey Extract, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Extract, Oligopeptide-10, Boswellia Serrata Extract, Behenyl Alcohol, Glycerin, Xanthan Gum, Caprylyl Glycol, Hexylene Glycol, Butylene Glycol, Phenoxyethanol, Fragrance (Parfum), Citric Acid, Sodium Hydroxide, Ethylhexylglycerin, Disodium EDTA, Disodium Carboxyethyl Siliconate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491)

  • STORAGE AND HANDLING

    Store in a cool, dry place. Avoid product contactwith silver jewelry, which may be discolored by this product.

  • PRINCIPAL DISPLAY PANEL

    Principle Display Panel

  • PRINCIPAL DISPLAY PANEL

    Tube

  • INGREDIENTS AND APPEARANCE
    KATE SUMMERVILLE ERADIKATE 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-263
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)  
    OAT BRAN (UNII: KQX236OK4U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DISODIUM CARBOXYETHYL SILICONATE (UNII: 4U4C79679G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HONEY (UNII: Y9H1V576FH)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERETH-18 (UNII: SA5E43C17C)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11090-263-021 in 1 BOX02/01/2022
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/01/2022
    Labeler - Beauty Manufacturing Solutions Corp. (783200723)
    Registrant - Beauty Manufacturing Solutions Corp. (783200723)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Manufacturing Solutions Corp.783200723manufacture(11090-263)