ERADIKATE ACNE TREATMENT- sulfur liquid 
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 Acne Treatment (43479-106)

ACTIVE INGREDIENTS:

SULFUR, 10%

PURPOSE

ACNE TREATMENT

USES

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

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

DIRECTIONS

OTHER INFORMATION

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)

EradiKate_Carton_080216_OL

0-LBL_EradiKate Acne Treatment_30mL_DF Box

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)

Revised: 1/2022
Document Id: d53fc4bb-2aab-87f1-e053-2995a90ac5d1
Set id: 713093d9-29c3-44c9-b90f-ee7448c5063e
Version: 6
Effective Time: 20220110
 
Kate Somerville Skincare, LLC