OTC Medication Information: EradiKate Facial Mask

ERADIKATE FACIAL MASK- sulfur lotion
Kate Somerville Skincare, LLC

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

EridiKateMask_Carton_012516OL
(click image for full-size original)

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 Drug M006 06/15/2014
Labeler — Kate Somerville Skincare, LLC (615155533)

Revised: 01/2024 Kate Somerville Skincare, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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