OTC Medication Information: EradiKate Facial Mask

ERADIKATE FACIAL MASK- sulfur lotion
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:

SULFUR, 5%

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

• USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.
• AVOID CONTACT WITH EYES. IF EXCESSIVE SKIN IRRITATION DEVELOPS OR INCREASES, DISCONTINUE USE AND CONSULT A DOCTOR.

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

• CLEANSE SKIN THOROUGHLY BEFORE APPLYING. COVER THE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH 1 APPLICATION DAILY, THEN GRADUALLY INCREASE TO 2 OR 3 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

• DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO SULFUR.
• YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-981-KATE ON WEEKDAYS 9A.M.-5P.M. PACIFIC TIME.

INACTIVE INGREDIENT

Acrylates Copolymer, Avena Sativa (Oat) Extract, Behenyl Alcohol, Boswellia Serrata Extract, Butylene Glycol, Cetearyl Alcohol, Citric Acid, Cocamidopropyl Hydroxysultaine, Coco Glucoside, Disodium Carboxyethyl Siliconate, Disodium EDTA, Ethyl Perfluorobutyl Ether, Ethyl Perfluoroisobutyl Ether, Ethylhexylglycerin, Fragrance (Parfum), Glycereth-18, Glycereth-18 Ethylhexanoate, Glycerin, Honey (Mel) Extract, Iron Oxide (CI 77491), Oligopeptide-10, Oryza Sativa (Rice) Bran Extract, Phenoxyethanol, Potassium Sorbate, Propanediol, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Cocoamphoacetate, Sodium Hydroxide, Stearyl Alcohol, Titanium Dioxide (CI 77891), Water/Aqua/Eau, Xanthan Gum

ERADIKATE FACIAL MASK sulfur lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43479-109 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (SULFUR) SULFUR 5 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER XANTHAN GUM CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) GLYCERETH-18 GLYCERETH-18 ETHYLHEXANOATE SODIUM C14-16 OLEFIN SULFONATE SODIUM COCOAMPHOACETATE COCAMIDOPROPYL HYDROXYSULTAINE PROPANEDIOL PHENOXYETHANOL ETHYLHEXYLGLYCERIN SODIUM CHLORIDE FERRIC OXIDE RED DISODIUM CARBOXYETHYL SILICONATE EDETATE DISODIUM COCO GLUCOSIDE CETOSTEARYL ALCOHOL DOCOSANOL STEARYL ALCOHOL SODIUM HYDROXIDE AVENA SATIVA WHOLE GLYCERIN POTASSIUM SORBATE BUTYLENE GLYCOL RICE BRAN BOSWELLIA SERRATA WHOLE HONEY PALMITOYL OLIGOPEPTIDE SODIUM BENZOATE ANHYDROUS CITRIC ACID ETHYL PERFLUOROBUTYL ETHER ETHYL PERFLUOROISOBUTYL ETHER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43479-109-51 1 BOTTLE in 1 BOX contains a BOTTLE (43479-109-11) 1 NDC:43479-109-11 60 mL in 1 BOTTLE This package is contained within the BOX (43479-109-51)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/15/2014

Labeler — Kate Somerville Skincare, LLC (615155533)

Revised: 07/2022 Kate Somerville Skincare, LLC