Drug Facts

Manufacturer
COSMETIQUE ACTIVE PRODUCTION | Interspray
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:12

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

clears acne blemishes penetrates pores to control acne blemishes helps prevent new acne blemishes from forming

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 children under 12 years ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 1.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • clears acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes from forming

Warnings

WARNINGS SECTION

For external use only

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
  • children under 12 years of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol denat., propanediol, glycolic acid, niacinamide, dimethyl isosorbide, pentylene glycol, sodium hydroxide, capitolize-26-buteth-26, PPG-26-buteth-26, hydroxyethylpiperazine ethane sulfonic acid, citric acid, PEG-30 glyceryl cocoate, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, capryloyl salicylic acid, biosaccharide gum-1, maltodextrin, phytic acid, polyquaternium-10, fragrance

Questions or comments?

OTC - QUESTIONS SECTION

1-888-LRP LABO

1-888-577-5226

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

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
1244193salicylic acid 1.5 % Topical SolutionPSN2
1244193salicylic acid 15 MG/ML Topical SolutionSCD2
1244193salicylic acid 1.5 % Topical SolutionSY2

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
69625-528-01La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment30 mL in 1 BOTTLE, DROPPERLIQUID302
69625-528-01La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment1 in 1 CARTONLIQUID12
69625-528-02La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment3 mL in 1 TUBELIQUID32
69625-528-02La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69625-528LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR ANTIACNE PORE REFINING ACNE TREATMENT (SALICYLIC ACID) LIQUID [COSMETIQUE ACTIVE PRODUCTION]2Current NDC, 4 package rows20231214_418d480c-4131-4262-bb56-d5b10bbf7dcb.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69625-52869625-528-01, 69625-528-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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 AntiAcne Pore Refining Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION418d480c-4131-4262-bb56-d5b10bbf7dcb2023-12-13WarningsExact identifier
ndc (package): 69625-528-02
ndc (package): 69625-528-01
ndc (product): 69625-528
ndc11 (package): 69625052801
ndc11 (package): 69625052802
spl id: bf420a7d-24ee-4246-8b2d-e05bb9cbf268
spl set id: 418d480c-4131-4262-bb56-d5b10bbf7dcb

Reported adverse events (FAERS/openFDA)#

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