Label: ERADIKATE FACIAL MASK- sulfur lotion
- NDC Code(s): 43479-109-11, 43479-109-51
- Packager: Kate Somerville Skincare, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 7, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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
- KEEP OUT OF REACH OF CHILDREN
-
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
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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
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INGREDIENTS AND APPEARANCE
ERADIKATE FACIAL MASK
sulfur lotionProduct 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 Drug M006 06/15/2014 Labeler - Kate Somerville Skincare, LLC (615155533)
