OTC Medication Information: ERADIKATE CLARIFYING ACNE CLEANSER

ERADIKATE CLARIFYING ACNE CLEANSER- salicylic acid 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 INGREDIENTS

SALICYLIC ACID 1%

PURPOSE

ACNE TREATMENT

USES

• FOR THE TREATMENT 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 PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• AM & PM. DISPENSE A QUARTER SIZED AMOUNT AND MASSAGE GENTLY ONTO WET FACE, AVOIDING EYE AREA. RINSE THOROUGHLY AND PAT DRY.
• IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.

INACTIVE INGREDIENTS

AQUA/WATER/EAU, COCAMIDOPROPYL HYDROXYSULTAINE, DISODIUM COCOYL GLUTAMATE, MALTOOLIGOSYL GLUCOSIDE, HYDROGENATED STARCH HYDROSYLATE, PROPANEDIOL, SODIUM COCOYL GLUTAMATE, NIACINAMIDE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, GLYCERIN, LACTOBACILLUS FERMENT, CITRULLUS VULGARIS (WATERMELON) FRUIT EXTRACT, LENS ESCULENTA (LENTIL) FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, PEG-9 COCOATE, POLYGLYCERYL-6 RICINOLEATE, POLYGLYCERYL-6 CAPRYLATE, POLYGLYCERYL-4 COCOATE, POLYGLYCERYL-4 CAPRATE, PROPYLENE GLYCOL, POLYSORBATE 20, PEG-32 DISTEARATE, PEG-175 DISTEARATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, 1,2-HEXANEDIOL, SACCHARIDE ISOMERATE, SODIUM LACTATE, SODIUM PCA, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, MALTODEXTRIN, THYMOL, TERPINEOL, SORBETH-450 TRISTEARATE, CAPRYLHYDROXAMIC ACID, SODIUM CITRATE, SODIUM BENZOATE, POTASSIUM SORBATE, CITRIC ACID, SODIUM CHLORIDE, DISODIUM EDTA, SODIUM HYDROXIDE

ERADIKATE CLARIFYING ACNE CLEANSER salicylic acid gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43479-114 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER COCAMIDOPROPYL HYDROXYSULTAINE DISODIUM COCOYL GLUTAMATE MALTOOLIGOSYL GLUCOSIDE HYDROGENATED STARCH HYDROLYSATE PROPANEDIOL SODIUM COCOYL GLUTAMATE NIACINAMIDE ROSEMARY OIL GLYCERIN LACTOBACILLUS FERMENTUM WATERMELON LENTIL APPLE PEG-9 OLEATE POLYGLYCERYL-6 RICINOLEATE POLYGLYCERYL-6 CAPRYLATE POLYGLYCERYL-4 OLEATE POLYGLYCERYL-4 CAPRATE PROPYLENE GLYCOL POLYSORBATE 20 PEG-32 DISTEARATE PEG-175 DISTEARATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 1,2-HEXANEDIOL SACCHARIDE ISOMERATE SODIUM LACTATE SODIUM PYRROLIDONE CARBOXYLATE POLYDEXTROSE ICODEXTRIN AMYLOPECTIN, UNSPECIFIED SOURCE MALTODEXTRIN THYMOL TERPINEOL SORBETH-12 CAPRYLHYDROXAMIC ACID SODIUM CITRATE SODIUM BENZOATE POTASSIUM SORBATE ANHYDROUS CITRIC ACID SODIUM CHLORIDE EDETATE DISODIUM SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43479-114-54 1 TUBE in 1 BOX contains a TUBE (43479-114-14) 1 NDC:43479-114-14 120 mL in 1 TUBE This package is contained within the BOX (43479-114-54)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/01/2021

Labeler — KATE SOMERVILLE SKINCARE, LLC (615155533)

Revised: 08/2022 KATE SOMERVILLE SKINCARE, LLC