Label: ERADIKATE MATTIFYING ACNE- salicylic acid cream
- NDC Code(s): 43479-113-02, 43479-113-51
- Packager: KATE SOMERVILLE SKINCARE, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 25, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
- AM AND/OR PM. APPLY A THIN, EVEN LAYER TO CLEAN, DRY SKIN. AVOID EYE AREA. SHOULD BE APPLIED AFTER TREATMENT STEP AND BEFORE MAKEUP + SPF.
- BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY, THEN GRADUALLY INCREASE TO TWO OT THREE 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.
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INACTIVE INGREDIENTS
AQUA/WATER/EAU, KAOLIN, ISODODECANE, MAGNESIUM ALUMINUM SILICATE, NIACINAMIDE, DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL, HYDROLYZED YEAST PROTEIN, POLYSILICONE-11, POLYACRYLATE CROSSPOLYMER-6, PPG-26-BUTETH-26, CURCUMA WENYUJIN/CURCUMA KWANGSIENSIS RHIZOME EXTRACT, ORYZA SATIVA (RICE) BRAN EXTRACT, MEL/HONEY EXTRACT/EXTRAIT DE MIEL, BOSWELLIA SERRATA EXTRACT, SODIUM HYALURONATE, PROLINE, HYDROXYPROLINE, ETHYLHEXYLGLYCERIN, HYDROLYZED VEGETABLE PROTEIN, NORDIHYDROGUAIARETIC ACID, OLEANOLIC ACID, BIOTIN, SODIUM PCA, 1,2-HEXANEDIOL, GLYCERYL STEARATE, PEG-40 HYDROGENATED CASTOR OIL, CETEARYL ALCOHOL, CETEARETH-20, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCO-CAPRYLATE/CAPRATE, PEG-100 STEARATE, HYDROXYETHYLCELLULOSE, SACCHARIDE ISOMERATE, ETHYL LINOLEATE, PEG-60 ALMOND GLYCERIDES, CAPRYLYL GLYCOL, GLYCERIN, PHOSPHOLIPIDS, HYDROGENATED VEGETABLE OIL, PENTYLENE GLYCOL, TOCOPHERYL ACETATE, PANTHENOL, T-BUTYL ALCOHOL, DECYL GLUCOSIDE, SODIUM CITRATE, HEXYLENE GLYCOL, CARBOMER, HEXYLRESORCINOL, CAPRYLHYDROXAMIC ACID, XANTHAN GUM, THYMOL, TERPINEOL, SODIUM HYDROXIDE, DISODIUM EDTA, PHENOXYETHANOL, SODIUM METABISULFITE, SODIUM BENZOATE, CITRIC ACID
- OTHER INFORMATION
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ERADIKATE MATTIFYING ACNE
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43479-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 mL Inactive Ingredients Ingredient Name Strength NIACINAMIDE (UNII: 25X51I8RD4) DIMETHICONE (UNII: 92RU3N3Y1O) PROPANEDIOL (UNII: 5965N8W85T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P) CURCUMA AROMATICA ROOT (UNII: C7X957O5YS) CURCUMA KWANGSIENSIS ROOT (UNII: 2WSI2681TI) RICE BRAN (UNII: R60QEP13IC) HONEY (UNII: Y9H1V576FH) BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROLINE (UNII: 9DLQ4CIU6V) HYDROXYPROLINE (UNII: RMB44WO89X) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LUTEIN (UNII: X72A60C9MT) NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) BIOTIN (UNII: 6SO6U10H04) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) PEG-100 STEARATE (UNII: YD01N1999R) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) SACCHARIDE ISOMERATE (UNII: W8K377W98I) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) PENTYLENE GLYCOL (UNII: 50C1307PZG) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) HEXYLRESORCINOL (UNII: R9QTB5E82N) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) XANTHAN GUM (UNII: TTV12P4NEE) THYMOL (UNII: 3J50XA376E) TERPINEOL (UNII: R53Q4ZWC99) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE SODIUM (UNII: MP1J8420LU) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) KAOLIN (UNII: 24H4NWX5CO) ISODODECANE (UNII: A8289P68Y2) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43479-113-51 1 in 1 BOX 04/01/2021 1 50 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:43479-113-02 2 mL in 1 PACKET; Type 0: Not a Combination Product 02/25/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 04/01/2021 Labeler - KATE SOMERVILLE SKINCARE, LLC (615155533)
