EradiKate ACNE TREATMENT

Manufacturer: Kate Somerville Skincare, LLC
Effective date: 2025-01-12
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 00:52:27

Label at a glance#

ProductEradiKate ACNE TREATMENT

Active ingredientSULFUR

Label structure11 sections

Contacts and useful links#

PhoneLabel contact1-800-981-KATE

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

SULFUR, 10%

OTC - PURPOSE SECTION

PURPOSE

ACNE TREATMENT

INDICATIONS & USAGE SECTION

USES

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

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

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

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 SECTION

INACTIVE INGREDIENT

ISOPROPYL ALCOHOL, WATER/AQUA/EAU, CAMPHOR, MAGNESIUM ALUMINUM SILICATE, SALICYLIC ACID, IRON OXIDES (CI 77489, CI 77491, CI 77492, CI 77499), ZINC OXIDE (CI 77947)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EradiKate_Carton_080216_OL

0-LBL_EradiKate Acne Treatment_30mL_DF Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198869	sulfur 10 % Topical Solution	PSN	8
198869	sulfur 100 MG/ML Topical Solution	SCD	8
198869	sulfur 10 % Topical Solution	SY	8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43479-106-51	2025-01-12	C162847	48780-1	1030e365-1aad-111a-e063-dadaa90a10e2	Kate Somerville (as PLD) - EradiKate Acne Treatment (43479-106)
43479-106-51	2024-01-30	C162847	48780-1	1030e365-1aad-111a-e063-dadaa90a10e2	Kate Somerville (as PLD) - EradiKate Acne Treatment (43479-106)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43479-106-11	EradiKate ACNE TREATMENT	30 mL in 1 BOTTLE, GLASS	LIQUID	30		8
43479-106-51	EradiKate ACNE TREATMENT	1 in 1 BOX	LIQUID	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43479-106	ERADIKATE ACNE TREATMENT (SULFUR) LIQUID [KATE SOMERVILLE SKINCARE, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20250113_713093d9-29c3-44c9-b90f-ee7448c5063e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	1
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
FERROUS OXIDE	INACTIVE INGREDIENT	G7036X8B5H	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	1
SALICYLIC ACID	INACTIVE INGREDIENT	O414PZ4LPZ	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

EradiKate ACNE TREATMENT
SULFUR
ISOPROPYL ALCOHOL
WATER
CAMPHOR (NATURAL)
MAGNESIUM ALUMINUM SILICATE
SALICYLIC ACID
FERROUS OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43479-106	43479-106-11, 43479-106-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ISOPROPYL ALCOHOL	ND2M416302	IACT
WATER	059QF0KO0R	IACT
CAMPHOR (NATURAL)	N20HL7Q941	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
FERROUS OXIDE	G7036X8B5H	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
ZINC OXIDE	SOI2LOH54Z	IACT
SULFUR	70FD1KFU70	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 141 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii+route 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CREAM / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 21 equally ranked IID candidates
FERROUS OXIDE	FERROUS OXIDE	G7036X8B5H	TABLET / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LIQUID / ORAL	82 mg/5ml		Exact identifier — unii+dosage form 12 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 21 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii+route 21 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	GRANULE, FOR SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER / RESPIRATORY (INHALATION)	0.04 mg		Exact identifier — unii candidate 60 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE / ORAL		14 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 60 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE / ORAL		14 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route 21 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CREAM / TOPICAL	3 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER / RESPIRATORY (INHALATION)	0.04 mg		Exact identifier — unii candidate 60 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LIQUID / ORAL	82 mg/5ml		Exact identifier — unii+dosage form 12 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii+route 3 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	GRANULE, FOR SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	FILM / BUCCAL	0.27 mg		Exact identifier — unii candidate 60 equally ranked IID candidates
FERROUS OXIDE	FERROUS OXIDE	G7036X8B5H	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERROUS OXIDE	FERROUS OXIDE	G7036X8B5H	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL		2 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii+route 21 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	FILM / BUCCAL	0.27 mg		Exact identifier — unii candidate 60 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, CHEWABLE / ORAL		14 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, CHEWABLE / ORAL		14 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, COATED / ORAL	0.11 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / BUCCAL		1 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii+route 21 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, COATED / ORAL	0.11 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / BUCCAL		1 mg	Exact identifier — unii candidate 60 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii+route 21 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EradiKate ACNE TREATMENT	SULFUR	Kate Somerville Skincare, LLC	713093d9-29c3-44c9-b90f-ee7448c5063e	2025-01-12	Warnings	Exact identifier ndc (package): 43479-106-51 ndc (package): 43479-106-11 ndc (product): 43479-106 ndc11 (package): 43479010651 ndc11 (package): 43479010611 spl id: 2b826d62-b44e-974d-e063-6394a90a109d spl set id: 713093d9-29c3-44c9-b90f-ee7448c5063e

Reported adverse events (FAERS/openFDA)#

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