FDA.reportPublic FDA data

Sulfur Spot Treatment

Manufacturer
Banuskin, Inc.
Effective date
2025-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:13

Label at a glance#

ProductSulfur Spot Treatment
Active ingredientSULFUR
Label structure14 sections

Indications and uses

For the treatment of acne

Dosage and administration

Directions Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. 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#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sulfur 10%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product

  • skin irritation and dryness 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.

Do not use on

OTC - DO NOT USE SECTION

Do not use on

  • broken skin
  • large areas of the skin

When using this product

OTC - WHEN USING SECTION

When using this product

  • apply only to areas with acne

Keep out of reach of children.

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.

Directions

INSTRUCTIONS FOR USE SECTION

Directions

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • 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

Aqua/Water/Eau, Glycerin, Kaolin, Bentonite, Propylene Glycol, Niacinamide, Sorbitol, Titanium Dioxide (Cl 77891), Phenoxyethanol, Hamamelis Virginiana (Witch Hazel) Water, Acacia Senegal Gum, Xanthan Gum, Alpha-Glucan Oligosaccharide, Carbomer, Poiyglyceryl-4 Caprate, Polyglyceryl-6 Caprylate, Chromium Oxide Green (Cl 77288), Butylene Glycol, Potassium Sorbate, Sodium Benzoate, Glycyrrhiza Glabra (Licorice) Root Extract, Salix Nigra (Willow) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Benzoic Acid.

Principal Display Panel

SPL UNCLASSIFIED SECTION

banu

SULFUR SPOT TREATMENT

10% Sulfur Acne Treatment

SAFE FOR ACNE-PRONE SKIN

15 mL/0.5 fl.oz.

DOSAGE & ADMINISTRATION SECTION

Topical Cream

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 mL Tube Carton

Spot-boxSpot-box

15 mL Tube

Spot-prySpot-pry

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
315220sulfur 10 % Topical CreamPSN1
315220sulfur 100 MG/ML Topical CreamSCD1
315220sulfur 10 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85439-0102-1Sulfur Spot Treatment15 mL in 1 TUBECREAM151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85439-0102SULFUR SPOT TREATMENT (SULFUR ACNE TREATMENT) CREAM [BANUSKIN, INC.]1Current NDC, 1 package rows20250417_31e527e0-ce37-e920-e063-6394a90ac827.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85439-010285439-0102-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-6 CAPRYLATEDGV8R54VG7IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SODIUM BENZOATEOJ245FE5EUIACT
BENZOIC ACID8SKN0B0MIMIACT
SULFUR70FD1KFU70ACTIB
CARBOMER0A5MM307FCIACT
WATER059QF0KO0RIACT
KAOLIN24H4NWX5COIACT
BENTONITEA3N5ZCN45CIACT
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER8FP93ED6H2IACT
XANTHAN GUMTTV12P4NEEIACT
CHROMIUM OXIDE GREENSX5Z09SU859IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WILLOW BARKS883J9JDYXIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
ACACIA SENEGAL GUM5C5403N26OIACT
ALPHA-GLUCAN OLIGOSACCHARIDES95658MI3WIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
NIACINAMIDE25X51I8RD4IACT
POLYGLYCERYL-4 CAPRATE3N873UN885IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HIACT

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
Sulfur Spot TreatmentSULFUR ACNE TREATMENTBanuskin, Inc.31e527e0-ce37-e920-e063-6394a90ac8272025-04-03WarningsExact identifier
ndc (package): 85439-0102-1
ndc (product): 85439-0102
ndc11 (package): 85439010201
spl id: 31e527e0-ce38-e920-e063-6394a90ac827
spl set id: 31e527e0-ce37-e920-e063-6394a90ac827

Reported adverse events (FAERS/openFDA)#

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