Label: ERADIKATE ACNE TREATMENT- sulfur liquid

  • 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 January 10, 2022

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    SULFUR, 10%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USES

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

    WARNINGS

    FOR EXTERNAL USE ONLY

  • WHEN USING

    WHEN USING THIS PRODUCT

    • USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE 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.
    • AVOID CONTACT WITH EYES. IF EXCESSIVE SKIN IRRITATION DEVELOPS OR INCREASES, DISCONTINUE USE AND CONSULT A DOCTOR.
  • STOP USE

    STOP USE AND ASK A DOCTOR IF SKIN IRRITATION 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.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • CLEANSE SKIN THOROUGHLY BEFORE APPLYING. COVER THE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH 1 APPLICATION DAILY, THEN GRADUALLY INCREASE TO 2 OR 3 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 SAFETY INFORMATION

    OTHER INFORMATION

    • DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO SULFUR.
    • YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-981-KATE ON WEEKDAYS 9A.M.-5P.M. PACIFIC TIME.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT

    ISOPROPYL ALCOHOL, WATER/AQUA/EAU, CAMPHOR, MAGNESIUM ALUMINUM SILICATE, SALICYLIC ACID, IRON OXIDES (CI 77489, CI 77491, CI 77492, CI 77499), ZINC OXIDE (CI 77947)

  • PRINCIPAL DISPLAY PANEL

    EradiKate_Carton_080216_OL

    0-LBL_EradiKate Acne Treatment_30mL_DF Box

  • INGREDIENTS AND APPEARANCE
    ERADIKATE ACNE TREATMENT 
    sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43479-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43479-106-511 in 1 BOX06/15/2014
    1NDC:43479-106-1130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/15/2014
    Labeler - Kate Somerville Skincare, LLC (615155533)
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