FDA.reportPublic FDA data

Sulfur Lotion

Manufacturer
Renu Laboratories, LLC
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:25:48

Label at a glance#

ProductRenu Laboratories Acne Sulphur L
Active ingredientSULFUR
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sulfur Colloidal (10%)

OTC - PURPOSE SECTION

Purpose

Topical Acne Treatment

INDICATIONS & USAGE SECTION

Uses

  • for the treatment of acne
  • healing and drying acne breakouts
  • helps clear acne pimples, blackheads or whiteheads and allows skin to heal
  • penetrates pores to control acne blemishes
  • helps keep skin clear of new acne pimples

WARNINGS SECTION

Warnings

For external use only

  • 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.

OTC - DO NOT USE SECTION

Do Not Use

  • on broken skin
  • on large areas of the skin
  • if pregnant or breast-feeding, ask a health professional before use.

OTC - WHEN USING SECTION

When using this product

  • apply only to areas with acne

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • excessive dryness or peeling 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

  • shake well
  • 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 INGREDIENT SECTION

Inactive ingredients

Camphor, Iron Oxide, Isopropyl Alcohol, Magnesium Aluminum Silicate, Salicylic Acid, Zinc Oxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Renu Sulfur LotionRenu Sulfur Lotion

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240725sulfur 10 % Topical LotionPSN6
240725sulfur 100 MG/ML Topical LotionSCD6
240725sulfur 10 % Topical LotionSY6

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
76348-450-022025-12-16C16284748780-12cef2736-7299-d83d-e063-dadaa90ab31fSulfur Lotion
76348-450-022025-01-30C16284748780-12cef2736-7299-d83d-e063-dadaa90ab31fSulfur Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-450-02Renu Laboratories Acne Sulphur L56 g in 1 BOTTLE, GLASSSUSPENSION566

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU702
SULFURACTIVE MOIETY70FD1KFU702
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ET2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163022
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC2
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ2
WATERINACTIVE INGREDIENT059QF0KO0R2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-45076348-450-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675IACT
WATER059QF0KO0RIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
ZINC OXIDESOI2LOH54ZIACT
SALICYLIC ACIDO414PZ4LPZIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
ISOPROPYL ALCOHOLND2M416302IACT
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 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+dosage form
10 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
2 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii+route
2 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLOTION / TOPICAL1.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / RECTAL14480 mgExact identifier — unii+dosage form
10 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii+route
10 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / RECTAL14480 mgExact identifier — unii+dosage form
10 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
4 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLOTION / TOPICAL1.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
4 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+dosage form
10 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
4 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
4 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 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
Renu Laboratories Acne Sulphur LACNE SULFUR LOTIONRenu Laboratories, LLC13de0e4c-b134-41c0-e054-00144ff88e882025-12-16WarningsExact identifier
ndc (package): 76348-450-02
ndc (product): 76348-450
ndc11 (package): 76348045002
spl id: 4616a187-4faa-181d-e063-6294a90ae910
spl set id: 13de0e4c-b134-41c0-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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