ERADIKATE FACIAL MASK- sulfur lotion

EradiKate Facial Mask by

Drug Labeling and Warnings

EradiKate Facial Mask 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

ACTIVE INGREDIENTS:

SULFUR, 5%

PURPOSE

PURPOSE

ACNE TREATMENT

INDICATIONS & USAGE

USES

• FOR THE TRETAMENT OF ACNE
• HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

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

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION 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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ERADIKATE FACIAL MASK 
sulfur lotion

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GLYCERETH-18 (UNII: SA5E43C17C)
GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
PROPANEDIOL (UNII: 5965N8W85T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DISODIUM CARBOXYETHYL SILICONATE (UNII: 4U4C79679G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
COCO GLUCOSIDE (UNII: ICS790225B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DOCOSANOL (UNII: 9G1OE216XY)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
RICE BRAN (UNII: R60QEP13IC)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
HONEY (UNII: Y9H1V576FH)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ETHYL PERFLUOROBUTYL ETHER (UNII: 520BW6FQ5U)
ETHYL PERFLUOROISOBUTYL ETHER (UNII: G60AS0OTNS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43479-109-51	1 in 1 BOX	06/15/2014
1	NDC: 43479-109-11	60 mL in 1 BOTTLE; Type 0: Not a Combination Product

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)