FDA.reportPublic FDA data

Neutrogena Stubborn Acne Spot Drying

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:41:10

Label at a glance#

ProductNeutrogena Stubborn Acne Spot Drying
Active ingredientSULFUR
Label structure11 sections

Dosage and administration

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. Sensitivity Test for...

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sulfur 10%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from fire or flame

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes. If contact occurs, immediately flush with water.
  • 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.

Do not use on

OTC - DO NOT USE SECTION

▪ broken skin ▪ large areas of the skin

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

DOSAGE & ADMINISTRATION SECTION

  • 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.
  • Sensitivity Test for a New user: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Isopropyl Alcohol, Water, Calamine, Niacinamide, Zinc Oxide, Zea Mays (Corn) Starch, Magnesium Aluminum Silicate, Salicylic Acid, Titanium Dioxide

Questions?

OTC - QUESTIONS SECTION

800-582-4048; outside US, dial collect 215-273-8755 or visit www.neutrogena.com

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 29mL Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

NEW

STUBBORN

ACNE

SPOT DRYING LOTION

Sulfur Acne Treatment

10% Sulfur +

4% Niacinamide

Fragrance Free

clears acne by drying up

and shrinking pimples

1 FL OZ (29mL)

Neutrogena_1Neutrogena_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240725sulfur 10 % Topical LotionPSN4
240725sulfur 100 MG/ML Topical LotionSCD4
240725sulfur 10 % Topical LotionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0761-1Neutrogena Stubborn Acne Spot Drying29 mL in 1 BOTTLELOTION294
69968-0761-1Neutrogena Stubborn Acne Spot Drying1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0761NEUTROGENA STUBBORN ACNE SPOT DRYING (SULFUR) LOTION [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 2 package rows20241208_dffe9bf4-a8a2-4fa0-e053-2995a90abcb3.zip

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
69968-076169968-0761-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
SULFUR70FD1KFU70ACTIB
ISOPROPYL ALCOHOLND2M416302IACT
NIACINAMIDE25X51I8RD4IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SALICYLIC ACIDO414PZ4LPZIACT

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
Neutrogena Stubborn Acne Spot DryingSULFURKenvue Brands LLCdffe9bf4-a8a2-4fa0-e053-2995a90abcb32024-11-26WarningsExact identifier
ndc (package): 69968-0761-1
ndc (product): 69968-0761
ndc11 (package): 69968076101
spl id: 27cea92e-bff9-b3b2-e063-6394a90a7f08
spl set id: dffe9bf4-a8a2-4fa0-e053-2995a90abcb3

Reported adverse events (FAERS/openFDA)#

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