ERADIKATE DAILY FOAMING CLEANSER  ACNE TREATMENT- sulfur gel 
Kate Somerville Skincare, LLC

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.

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Kate Somerville Skincare - EradiKate Daily Foaming Cleanser (43479-110)

ACTIVE INGREDIENT

SULFUR  3.0%

PURPOSE

ACNE TREATMENT

USES

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

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

DIRECTIONS

OTHER INFORMATION

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)

0-UC_EradiKate Cleanser_120mL

0-LBL_EradiKate Cleanser_120mL

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)

Revised: 8/2022
Document Id: e54964f6-8981-d9bb-e053-2a95a90a6227
Set id: bebe3042-b80c-41ca-b8df-48093573c082
Version: 7
Effective Time: 20220802
 
Kate Somerville Skincare, LLC