Label: ERADIKATE DAILY FOAMING CLEANSER ACNE TREATMENT- sulfur gel

  • NDC Code(s): 43479-110-11, 43479-110-12, 43479-110-13, 43479-110-14, view more
    43479-110-51
  • Packager: Kate Somerville Skincare, LLC
  • 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 August 2, 2022

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  • ACTIVE INGREDIENT

    SULFUR  3.0%

  • PURPOSE

    ACNE TREATMENT

  • USES

    • FOR THE TRETAMENT OF ACNE
    • HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES
  • WARNINGS

    FOR EXTERNAL USE ONLY

  • WHEN USING

    WHEN USING THIS PRODUCT

    • 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

    STOP USE AND ASK A DOCTOR IF RASH OCCURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • 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 EXCESSIVE DRYNESS 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.
  • OTHER INFORMATION

    • STORE IN A COOL, DRY PLACE. AVOID PRODUCT CONTACT WITH SILVER JEWELRY, WHICH MAY BE DISCOLORED BY THIS PRODUCT.

  • INACTIVE INGREDIENTS

    WATER/AQUA/EAU, SODIUM COCOYL ISETHIONATE, COCO-GLUCOSIDE, ACRYLATES COPOLYMER, COCONUT ALCOHOL, GLYCERETH-18 ETHYLHEXANOATE, GLYCERETH-18, STEARYL ALCOHOL, HONEY EXTRACT/MEL/EXTRAIT DE MIEL, ORYZA SATIVA (OAT) KERNEL EXTRACT, OLIGOPEPTIDE-10, BOSWELLIA SERRATA EXTRACT, BEHENYL ALCOHOL, GLYCERIN, PHENOXYETHANOL, FRAGRANCE/PARFUM, CITRIC ACID, SODIUM HYDROXIDE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, DISODIUM CARBOXYETHYL SILICONATE, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491)

  • PRINCIPAL DISPLAY PANEL

    0-UC_EradiKate Cleanser_120mL

    0-LBL_EradiKate Cleanser_120mL

  • INGREDIENTS AND APPEARANCE
    ERADIKATE DAILY FOAMING CLEANSER   ACNE TREATMENT
    sulfur gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43479-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)  
    GLYCERETH-18 (UNII: SA5E43C17C)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    HONEY (UNII: Y9H1V576FH)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
    BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISODIUM CARBOXYETHYL SILICONATE (UNII: 4U4C79679G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43479-110-511 in 1 BOX10/12/2018
    1NDC:43479-110-13120 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:43479-110-1250 mL in 1 TUBE; Type 0: Not a Combination Product10/12/2018
    3NDC:43479-110-1130 mL in 1 TUBE; Type 0: Not a Combination Product10/12/2018
    4NDC:43479-110-14240 mL in 1 TUBE; Type 0: Not a Combination Product10/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/12/2018
    Labeler - Kate Somerville Skincare, LLC (615155533)
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