FDA.reportPublic FDA data

EradiKate ACNE TREATMENT

Manufacturer
Rare Beauty Brands Inc
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:18:49

Label at a glance#

ProductEradiKate ACNE TREATMENT
Active ingredientSULFUR
Label structure11 sections

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_OLEradiKate_Carton_080216_OL

0-LBL_EradiKate Acne Treatment_30mL_DF Box0-LBL_EradiKate Acne Treatment_30mL_DF Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198869sulfur 10 % Topical SolutionPSN9
198869sulfur 100 MG/ML Topical SolutionSCD9
198869sulfur 10 % Topical SolutionSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72204-901-01EradiKate ACNE TREATMENT30 mL in 1 BOTTLE, GLASSLIQUID309
72204-901-02EradiKate ACNE TREATMENT1 in 1 BOXLIQUID19

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72204-90172204-901-01, 72204-901-02

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
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SALICYLIC ACIDO414PZ4LPZIACT
FERROUS OXIDEG7036X8B5HIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ZINC OXIDESOI2LOH54ZIACT
SULFUR70FD1KFU70ACTIB

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
EradiKate ACNE TREATMENTSULFURRare Beauty Brands Inc44ebacf3-52c1-4896-e063-6394a90ac4472025-12-01WarningsExact identifier
ndc (package): 72204-901-02
ndc (package): 72204-901-01
ndc (product): 72204-901
ndc11 (package): 72204090101
ndc11 (package): 72204090102
spl id: 44eba48d-5fc8-38ea-e063-6394a90ad2e9
spl set id: 44ebacf3-52c1-4896-e063-6394a90ac447

Reported adverse events (FAERS/openFDA)#

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