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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc. | Englewood Lab, Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 00:06:05

Label at a glance#

ProductKiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot Treatment
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

Label contents#

Full prescribing information#

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

Do not use on

OTC - DO NOT USE SECTION

  • broken skin
  • large areas of the skin

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

water, niacinamide, zea mays (corn) starch, glycolic acid, stearyl alcohol, glycerin, octyldodecyl myristate, cetearyl alcohol, glyceryl stearate, magnesium aluminum silicate, phenoxyethanol, polyacrylamide, ceteareth-20, sodium hydroxide, PEG-100 stearate, phenylethyl resorcinol, tocopheryl acetate, C13-14 isoparaffin, disodium EDTA, laureth-7, allantoin, aloe barbadensis leaf juice, hydrogenated lecithin, ethylhexylglycerin, glycyrrhiza glabra (licorice) root extract

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-946-4453

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240725sulfur 10 % Topical LotionPSN12
240725sulfur 100 MG/ML Topical LotionSCD12
240725sulfur 10 % Topical LotionSY12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-895-01Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot Treatment20 mL in 1 TUBELOTION2012
49967-895-01Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot Treatment1 in 1 CARTONLOTION112
49967-895-02Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot Treatment3 mL in 1 PACKETLOTION312
49967-895-03Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot Treatment1.5 mL in 1 PACKETLOTION1.512
49967-895-04Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot Treatment3 mL in 1 TUBELOTION312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-895KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL TARGETED ACNE SPOT TREATMENT (SULFUR) LOTION [L'OREAL USA PRODUCTS INC]12Current NDC, Legacy NDC, 5 package rows20231231_217c697e-0260-46d5-a202-ce7345eadd94.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-89549967-895-01, 49967-895-02, 49967-895-03, 49967-895-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
GLYCOLIC ACID0WT12SX38SIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
PEG-100 STEARATEYD01N1999RIACT
PHENYLETHYL RESORCINOLG37UFG162OIACT
ALLANTOIN344S277G0ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot TreatmentSULFURL'Oreal USA Products Inc217c697e-0260-46d5-a202-ce7345eadd942023-12-30WarningsExact identifier
ndc (package): 49967-895-04
ndc (package): 49967-895-01
ndc (package): 49967-895-03
ndc (package): 49967-895-02
ndc (product): 49967-895
ndc11 (package): 49967089504
ndc11 (package): 49967089502
ndc11 (package): 49967089501
ndc11 (package): 49967089503
spl id: 1cb9aca2-b493-4ee2-85c9-0001329654fc
spl set id: 217c697e-0260-46d5-a202-ce7345eadd94

Reported adverse events (FAERS/openFDA)#

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