FDA.reportPublic FDA data

Acne treatment Nighttime

Manufacturer
Malin and Goetz Inc
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-10-10 01:02:13

Label at a glance#

ProductMalin and Goetz Acne Treatment
Active ingredientSULFUR
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient purpose

Sulfur 10% Acne Treatment

OTC - PURPOSE SECTION

Uses

  • treats acne
  • dries up acne pimples
  • helps prevent acne pimples

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.

INDICATIONS & USAGE 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.

WARNINGS SECTION

Warnings

For External Use only

When using this product

  • apply only to areas with acne

Do not use

  • on broken skin
  • or large areas of skin

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clean skin thoroughly before applying this product
  • cover the affected area with a thin layer once a day
  • if bothersome dryness or peeling occurs, reduce application to once every other day

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Salicylic Acid, Magnesium Aluminum Silicate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

(Malin + Goetz)

acne treatment nighttime

10% Sulfur lotion. Overnight Treatment

Advanced Technology

.5 fl. oz. 14ml

acne night treat cartonacne night treat carton

acne treat night jaracne treat night jar

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130891211000213GTIN-13: 0891211000213
EAN-13: 0891211000213
GTIN-12: 891211000213
UPC-A: 891211000213
GTIN storage (14 digits): 00891211000213		acne treatment nighttime bentley_Acne Treatment Nighttime Carton O 070620.jpg

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53634-010-022024-10-30C16284748780-11030e365-2c80-111a-e063-dadaa90a10e2Acne treatment Nighttime
53634-010-022024-10-30C16284748780-11030e365-2c80-111a-e063-dadaa90a10e2Acne treatment Nighttime
53634-010-022024-01-30C16284748780-11030e365-2c80-111a-e063-dadaa90a10e2Acne treatment Nighttime
53634-010-022024-01-30C16284748780-11030e365-2c80-111a-e063-dadaa90a10e2Acne treatment Nighttime

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU701
SULFURACTIVE MOIETY70FD1KFU701
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ET1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ1
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z1

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
53634-01053634-010-01, 53634-010-02

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
SULFUR70FD1KFU70ACTIB
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
SALICYLIC ACIDO414PZ4LPZIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-10-01full-release2026-06-01 01:15:27

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 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
21 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
6 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
21 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
21 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
3 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
21 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
3 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
21 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
3 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
21 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
21 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
6 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Malin and Goetz Acne TreatmentSULFURMalin and Goetz Inc47390813-6bc9-44f4-b72a-d399d2c0de272025-10-01WarningsExact identifier
ndc (package): 53634-010-02
ndc (package): 53634-010-01
ndc (product): 53634-010
ndc11 (package): 53634001001
ndc11 (package): 53634001002
spl set id: 47390813-6bc9-44f4-b72a-d399d2c0de27

Reported adverse events (FAERS/openFDA)#

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