Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:04

Label at a glance#

ProductKiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and Preventing
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

for the treatment of acne clears acne blemishes and allows skin to heal helps keep skin clear of new acne blemishes

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

Salicylic acid 1.2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • clears acne blemishes and allows skin to heal
  • helps keep skin clear of new acne blemishes

Warnings

WARNINGS SECTION

For external use only

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.

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 ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, butylene glycol, niacinamide, dimethicone, cetearyl alcohol, isohexadecane, sodium hydroxide, ammonium polyacryloyldimethyl taurate, laureth-4, polyacrylate crosspolymer-6, propylene glycol, dipotassium glycyrrhizate, hydroxyethylcellulose, dimethiconol, trisodium ethylenediamine disuccinate, zinc PCA, glyceryl stearate, PEG-100 stearate, silica silylate, hydroxypropyl starch phosphate, maltodextrin, menthol, lactobacillus ferment, salvia officinalis (sage) leaf extract, chamomilla recutita (matricaria) flower 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
2641586salicylic acid 1.2 % Topical LotionPSN2
2641586salicylic acid 12 MG/ML Topical LotionSCD2
2641586salicylic acid 1.2 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-057-01Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and Preventing1 in 1 CARTONLOTION12
49967-057-01Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and Preventing50 mL in 1 BOTTLE, PUMPLOTION502
49967-057-02Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and Preventing1 in 1 CARTONLOTION12
49967-057-02Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and Preventing15 mL in 1 TUBELOTION152
49967-057-03Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and Preventing60 mL in 1 TUBELOTION602
49967-057-03Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and Preventing1 in 1 CARTONLOTION12
49967-057-04Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and Preventing1 in 1 CARTONLOTION12
49967-057-04Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and Preventing5 mL in 1 TUBELOTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-057KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS EXPERTLY CLEAR ACNE TREATING AND PREVENTING (SALICYLIC ACID) LOTION [L'OREAL USA PRODUCTS INC]2Current NDC, 8 package rows20231231_14429a1d-7db9-49a7-85d6-22374d03ecaa.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-05749967-057-01, 49967-057-02, 49967-057-03, 49967-057-04

Ingredients#

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

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

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 Expertly Clear Acne Treating and PreventingSALICYLIC ACIDL'Oreal USA Products Inc14429a1d-7db9-49a7-85d6-22374d03ecaa2023-12-30WarningsExact identifier
ndc (package): 49967-057-04
ndc (package): 49967-057-03
ndc (package): 49967-057-01
ndc (package): 49967-057-02
ndc (product): 49967-057
ndc11 (package): 49967005702
ndc11 (package): 49967005704
ndc11 (package): 49967005703
ndc11 (package): 49967005701
spl id: 244d3124-90d7-4d12-949b-17c4cc80cf16
spl set id: 14429a1d-7db9-49a7-85d6-22374d03ecaa

Reported adverse events (FAERS/openFDA)#

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