FDA.reportPublic FDA data

KATE SOMERVILLE (as PLD) - Eradikate Mattifying Acne Gel Cream (43479-113)

Manufacturer
KATE SOMERVILLE SKINCARE, LLC
Effective date
2025-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:42:57

Label at a glance#

ProductEradikate Mattifying Acne
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

FOR THE TREATMENT OF ACNE HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES

Storage and handling

STORE IN A COOL, DRY PLACE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

SALICYLIC ACID 2%

PURPOSE

OTC - PURPOSE SECTION

ACNE TREATMENT

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

  • SKIN IRRITATION OR DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION SECTION

  • 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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

  • STORE IN A COOL, DRY PLACE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_EradiKate Mattifying Gel_1.7oz01b UC_EradiKate Mattifying Gel_1.7oz

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43479-113ERADIKATE MATTIFYING ACNE (SALICYLIC ACID) CREAM [KATE SOMERVILLE SKINCARE, LLC]5Legacy NDC20250113_9d79c1c8-3a6b-425e-9960-bf39d2c6f1fc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 63 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43479-11343479-113-51, 43479-113-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 62 matching rows.

Name, UNII, Kind table
NameUNIIKind
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
PROPANEDIOL5965N8W85TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
PPG-26-BUTETH-262II1K6TZ4PIACT
CURCUMA AROMATICA ROOTC7X957O5YSIACT
CURCUMA KWANGSIENSIS ROOT2WSI2681TIIACT
RICE BRANR60QEP13ICIACT
HONEYY9H1V576FHIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PROLINE9DLQ4CIU6VIACT
HYDROXYPROLINERMB44WO89XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
LUTEINX72A60C9MTIACT
NORDIHYDROGUAIARETIC ACID, (+/-)-7PZ73W4ZNRIACT
OLEANOLIC ACID6SMK8R7TGJIACT
BIOTIN6SO6U10H04IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
PEG-100 STEARATEYD01N1999RIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
PEG-60 ALMOND GLYCERIDES4Y0E651N0FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERINPDC6A3C0OXIACT
OMEGA-3 FATTY ACIDS71M78END5SIACT
HYDROGENATED COTTONSEED OILZ82Y2C65EAIACT
PENTYLENE GLYCOL50C1307PZGIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
44ebbe8d-d636-4cd8-e063-6394a90af7ab9d79c1c8-3a6b-425e-9960-bf39d2c6f1fc2025-12-01WarningsExact identifier
spl set id: 9d79c1c8-3a6b-425e-9960-bf39d2c6f1fc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.