EradiKate Daily Foaming Cleanser Acne Treatment: Package Insert and Label Information

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.

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 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 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

• 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)

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (SULFUR) SULFUR 3 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER SODIUM COCOYL ISETHIONATE COCO GLUCOSIDE CARBOMER COPOLYMER TYPE A COCONUT ALCOHOL GLYCERETH-18 ETHYLHEXANOATE GLYCERETH-18 STEARYL ALCOHOL HONEY ORYZA SATIVA WHOLE AVENA SATIVA WHOLE OLIGOPEPTIDE-10 BOSWELLIA SERRATA WHOLE DOCOSANOL GLYCERIN XANTHAN GUM CAPRYLYL GLYCOL HEXYLENE GLYCOL BUTYLENE GLYCOL PHENOXYETHANOL ANHYDROUS CITRIC ACID SODIUM HYDROXIDE ETHYLHEXYLGLYCERIN EDETATE DISODIUM DISODIUM CARBOXYETHYL SILICONATE TITANIUM DIOXIDE FERRIC OXIDE RED

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43479-110-51 1 TUBE in 1 BOX contains a TUBE (43479-110-13) 1 NDC:43479-110-13 120 mL in 1 TUBE This package is contained within the BOX (43479-110-51) 2 NDC:43479-110-12 50 mL in 1 TUBE None 3 NDC:43479-110-11 30 mL in 1 TUBE None 4 NDC:43479-110-14 240 mL in 1 TUBE None

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)

Revised: 08/2022 Kate Somerville Skincare, LLC