La Roche Posay Laboratoire Dermatologique Effaclar Clarifying

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:06:21

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Effaclar Clarifying
Active ingredientSALICYLIC ACID
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

Salicylic acid 0.5%

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

  • 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

Other information

USER SAFETY WARNINGS SECTION

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol denat., propanediol, glycolic acid, sodium hydroxide, capryloyl glycine, phenoxyethanol, benzyl alcohol, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, menthol, tremella fuciformis polysaccharide, butylene glycol, ophiopogon japonicus root extract, scutellaria baicalensis root extract

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199308salicylic acid 0.5 % Topical SolutionPSN10
199308salicylic acid 5 MG/ML Topical SolutionSCD10
199308salicylic acid 0.5 % Topical SolutionSY10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-024-01La Roche Posay Laboratoire Dermatologique Effaclar Clarifying200 mL in 1 BOTTLESOLUTION20010
49967-024-02La Roche Posay Laboratoire Dermatologique Effaclar Clarifying100 mL in 1 BOTTLESOLUTION10010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-024LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR CLARIFYING (SALICYLIC ACID) SOLUTION [L'OREAL USA PRODUCTS INC]10Current NDC, Legacy NDC, 2 package rows20240102_debff755-c83d-42c0-80fc-be73952eceb4.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 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-02449967-024-01, 49967-024-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
La Roche Posay Laboratoire Dermatologique Effaclar ClarifyingSALICYLIC ACIDL'Oreal USA Products Incdebff755-c83d-42c0-80fc-be73952eceb42024-01-01WarningsExact identifier
ndc (package): 49967-024-02
ndc (package): 49967-024-01
ndc (product): 49967-024
ndc11 (package): 49967002402
ndc11 (package): 49967002401
spl id: a54b7589-0951-4fad-ba26-958b89672de5
spl set id: debff755-c83d-42c0-80fc-be73952eceb4

Reported adverse events (FAERS/openFDA)#

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