ERADIKATE DAILY FOAMING CLEANSER ACNE TREATMENT- sulfur gel

EradiKate Daily Foaming Cleanser by

Drug Labeling and Warnings

EradiKate Daily Foaming Cleanser by is a Otc medication manufactured, distributed, or labeled by Kate Somerville Skincare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ERADIKATE DAILY FOAMING CLEANSER  ACNE TREATMENT
sulfur gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43479-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43479-110-51	1 in 1 BOX	10/12/2018
1	NDC: 43479-110-13	120 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43479-110-12	50 mL in 1 TUBE; Type 0: Not a Combination Product	10/12/2018
3	NDC: 43479-110-11	30 mL in 1 TUBE; Type 0: Not a Combination Product	10/12/2018
4	NDC: 43479-110-14	240 mL in 1 TUBE; Type 0: Not a Combination Product	10/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/12/2018

Labeler - Kate Somerville Skincare, LLC (615155533)