Kate Somerville (as Pld) - Eradikate Acne Treatment (43479-106)

SPL v9

SPL

SPL Set ID 44ebacf3-52c1-4896-e063-6394a90ac447

Route

TOPICAL

Published

Effective Date 2018-10-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Sulfur (10 g)

Inactive Ingredients

Isopropyl Alcohol Water Camphor (natural) Magnesium Aluminum Silicate Salicylic Acid Ferrous Oxide Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Zinc Oxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-06-15

Description

ACTIVE INGREDIENTS: SULFUR, 10%

Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

USES

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

Dosage and 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.

Description

ACTIVE INGREDIENTS: SULFUR, 10%

Section 50565-1

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

Section 50566-9

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

Section 50567-7

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.

Section 51727-6

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)

Section 51945-4

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENTS:

SULFUR, 10%

Section 60561-8

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.

Structured Label Content

Indications and Usage (34067-9)

USES

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

Section 50567-7 (50567-7)

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.

Section 51727-6 (51727-6)

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)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

SULFUR, 10%

Section 60561-8 (60561-8)

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.

Advanced Ingredient Data

[{"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (NATURAL)", "unii": "N20HL7Q941", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM ALUMINUM SILICATE", "unii": "6M3P64V0NC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROUS OXIDE", "unii": "G7036X8B5H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULFUR", "unii": "70FD1KFU70", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "USES FOR THE TRETAMENT OF ACNE HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES", "34068-7": "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.", "34071-1": "WARNINGS FOR EXTERNAL USE ONLY", "50565-1": "KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.", "50566-9": "STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.", "50567-7": "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.", "51727-6": "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)", "55105-1": "PURPOSE ACNE TREATMENT", "55106-9": "ACTIVE INGREDIENTS: SULFUR, 10%", "60561-8": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:24.201226 · Updated: 2026-03-14T23:10:48.259693