FDA.reportPublic FDA data

La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:06:15

Label at a glance#

ProductLa Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser
Active ingredientSALICYLIC ACID
Label structure10 sections

Dosage and administration

use twice daily wet face, then work product into a lather massage onto face, avoiding the eyes rinse well

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

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

  • use twice daily
  • wet face, then work product into a lather
  • massage onto face, avoiding the eyes
  • rinse well

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium laureth sulfate, decyl glucoside, glycerin, sodium chloride, coco-betaine, PEG-150 pentaerythrityl tetrastearate, hexylene glycol, sodium hydroxide, PEG-6 caprylic/capric glycerides, zinc gluconate, tetrasodium EDTA, polyquaternium-47, menthol, capryloyl salicylic acid, citric acid

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-023-01La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser200 mL in 1 TUBEGEL2007
49967-023-02La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser100 mL in 1 TUBEGEL1007
49967-023-03La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser15 mL in 1 TUBEGEL157
49967-023-04La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser3 mL in 1 PACKETGEL37
49967-023-05La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser200 mL in 1 TUBEGEL2007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-023LA ROCHE POSAY LABORATORIE DERMATOLOGIQUE EFFACLAR MEDICATED CLEANSER (SALICYLIC ACID) GEL [L'OREAL USA PRODUCTS INC]7Current NDC, Legacy NDC, 5 package rows20240101_8a6e2634-2497-403a-af03-113bf35fe36a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-02349967-023-01, 49967-023-02, 49967-023-03, 49967-023-04, 49967-023-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCO-BETAINE03DH2IZ3FYIACT
PEG-150 PENTAERYTHRITYL TETRASTEARATE8L4OOQ76AMIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
SODIUM HYDROXIDE55X04QC32IIACT
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESGO50W2HWO8IACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
MENTHOLL7T10EIP3AIACT
CAPRYLOYL SALICYLIC ACID5F7PJF6AA4IACT

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
La Roche Posay Laboratorie Dermatologique Effaclar Medicated CleanserSALICYLIC ACIDL'Oreal USA Products Inc8a6e2634-2497-403a-af03-113bf35fe36a2023-12-31WarningsExact identifier
ndc (package): 49967-023-02
ndc (package): 49967-023-03
ndc (package): 49967-023-05
ndc (package): 49967-023-04
ndc (package): 49967-023-01
ndc (product): 49967-023
ndc11 (package): 49967002302
ndc11 (package): 49967002304
ndc11 (package): 49967002303
ndc11 (package): 49967002305
ndc11 (package): 49967002301
spl id: 4f240059-6dd5-422b-8ffa-04c6019f4162
spl set id: 8a6e2634-2497-403a-af03-113bf35fe36a

Reported adverse events (FAERS/openFDA)#

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