FDA.reportPublic FDA data

Anti Acne Natural Volcanic Sulfur

Manufacturer
PT. GALENIUM PHARMASIA LABORATORIES | Galenium Pharmasia Laboratories, PT
Effective date
2025-01-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:53:35

Label at a glance#

ProductAnti Acne Natural Volcanic Sulfur
Active ingredientSULFUR
Label structure10 sections

Dosage and administration

Work up a lather using warm water and apply to affected area. Rinse thoroughly and pat dry. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Precipitated Sulfur 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Skin irritation and 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.
  • Apply only to areas with acne.

OTC - DO NOT USE SECTION

  • Do not use on broken skin.
  • Do not use on large areas of skin.
  • Do not get into eyes. If excessive skin Irritation develops or increases, discontinue use and consult a doctor.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Work up a lather using warm water and apply to affected area.
  • Rinse thoroughly and pat dry.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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

Saponified Palm and Palm Kernel Oil, Lanolin, Fragrance, Coconut Fatty Acid Diethanol Amide, Salicylic Acid 0.25%, Glycerin, Titanium Dioxide.

Questions or Comments

OTC - QUESTIONS SECTION

888-406-0151

SPL UNCLASSIFIED SECTION

Distributed by Dr. Joesoef Skin Care, LLC.
Boca Raton, Florida 33433 USA

PRINCIPAL DISPLAY PANEL - 20 g Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SULFUR 10%

NEW!

Joesoef™
SKIN CARE

Anti-Acne Soap
Natural Volcanic Sulfur 10%

For Oily to Normal Skin

Formulated & Developed
by Dermatologists for:

• Treatment of Acne
• Clogged pores
• Blackheads
• Blemishes

Net wt. 0.7 oz (20g)

Principal Display Panel - 120 g Box
Principal Display Panel - 120 g Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053330sulfur 10 % Medicated Liquid SoapPSN5
1053330sulfur 100 MG/ML Medicated Liquid SoapSCD5
1053330sulfur 10 % Medicated Liquid SoapSY5
1053330sulfur 10 % Topical MaskSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
26050-101-022025-01-23C16284748780-19d75b9d0-c0f1-f424-e053-dadaa90a57ceAnti-Acne Soap Natural Volcanic Sulfur 10%
26050-101-022023-07-28C16284748780-19d75b9d0-c0f1-f424-e053-dadaa90a57ceAnti-Acne Soap Natural Volcanic Sulfur 10%
26050-101-022022-03-02C16284748780-19d75b9d0-c0f1-f424-e053-dadaa90a57ceAnti-Acne Soap Natural Volcanic Sulfur 10%
26050-101-022022-01-28C16284748780-19d75b9d0-c0f1-f424-e053-dadaa90a57ceAnti-Acne Soap Natural Volcanic Sulfur 10%
26050-101-022020-02-25C16284748780-19d75b9d0-c0f1-f424-e053-dadaa90a57ceAnti-Acne Soap Natural Volcanic Sulfur 10%
26050-101-022020-01-31C16284748780-19d75b9d0-c0f1-f424-e053-dadaa90a57ceAnti-Acne Soap Natural Volcanic Sulfur 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
26050-101-02Anti Acne Natural Volcanic Sulfur20 g in 1 BOXSOAP205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
26050-101ANTI ACNE NATURAL VOLCANIC SULFUR (SULFUR) SOAP [PT. GALENIUM PHARMASIA LABORATORIES]5Current NDC, Legacy NDC, 1 package rows20250125_4f230abd-5c07-4121-81da-a9fa2d20a2ca.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU701
SULFURACTIVE MOIETY70FD1KFU701
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972D1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LANOLININACTIVE INGREDIENT7EV65EAW6H1
PALM KERNEL OILINACTIVE INGREDIENTB0S90M02331
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
26050-10126050-101-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZIACT
PALM KERNEL OILB0S90M0233IACT
LANOLIN7EV65EAW6HIACT
COCO DIETHANOLAMIDE92005F972DIACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SULFUR70FD1KFU70ACTIB

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 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route
10 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route
10 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DCREAM / TOPICAL30 mgExact identifier — unii+route
10 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSPONGE / TOPICAL2 %w/wExact identifier — unii+route
10 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSHAMPOO / TOPICAL600 mgExact identifier — unii+route
10 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSUSPENSION / TOPICAL4 %w/wExact identifier — unii+route
10 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii+route
10 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii+route
10 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSPONGE / TOPICAL2 %w/wExact identifier — unii+route
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSHAMPOO / TOPICAL600 mgExact identifier — unii+route
10 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DCREAM / TOPICAL30 mgExact identifier — unii+route
10 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSUSPENSION / TOPICAL4 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
10 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii+route
10 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIESa19ac01b-950a-4ddb-9711-17f15bdb40132025-01-23WarningsExact identifier
ndc (product): 26050-101
Anti Acne Natural Volcanic SulfurSULFURPT. GALENIUM PHARMASIA LABORATORIES4f230abd-5c07-4121-81da-a9fa2d20a2ca2025-01-23WarningsExact identifier
ndc (package): 26050-101-02
ndc (product): 26050-101
ndc11 (package): 26050010102
spl id: 2c6c21fe-607d-ff7d-e063-6294a90a935a
spl set id: 4f230abd-5c07-4121-81da-a9fa2d20a2ca

Reported adverse events (FAERS/openFDA)#

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