FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment

Manufacturer
L'Oreal USA Products Inc | COSMETIQUE ACTIVE PRODUCTION | Interspray
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:04:13

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Effaclar 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 cartonimage 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 SolutionPSN8
1244193salicylic acid 15 MG/ML Topical SolutionSCD8
1244193salicylic acid 1.5 % Topical SolutionSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-529-01La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment30 mL in 1 BOTTLE, DROPPERLIQUID308
49967-529-01La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment1 in 1 CARTONLIQUID18
49967-529-02La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment3 mL in 1 TUBELIQUID38
49967-529-02La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment1 in 1 CARTONLIQUID18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-529LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR PORE REFINING ACNE TREATMENT (SALICYLIC ACID) LIQUID [L'OREAL USA PRODUCTS INC]8Current NDC, Legacy NDC, 4 package rows20231214_5056320e-e472-44ed-9afd-759ba55f0fd7.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
49967-52949967-529-01, 49967-529-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
PROPANEDIOL5965N8W85TIACT
GLYCOLIC ACID0WT12SX38SIACT
NIACINAMIDE25X51I8RD4IACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
PENTYLENE GLYCOL50C1307PZGIACT
SODIUM HYDROXIDE55X04QC32IIACT
PPG-26-BUTETH-262II1K6TZ4PIACT
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACIDRWW266YE9IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PEG-30 GLYCERYL COCOATEFX3EB7VC3LIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
CAPRYLOYL SALICYLIC ACID5F7PJF6AA4IACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
MALTODEXTRIN7CVR7L4A2DIACT
FYTIC ACID7IGF0S7R8IIACT
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)PI1STR9QYHIACT

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 Pore Refining Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5056320e-e472-44ed-9afd-759ba55f0fd72023-12-13WarningsExact identifier
ndc (package): 49967-529-02
ndc (package): 49967-529-01
ndc (product): 49967-529
ndc11 (package): 49967052902
ndc11 (package): 49967052901
spl id: a56bbaaa-5b60-4a4b-953b-99d0abfda1c8
spl set id: 5056320e-e472-44ed-9afd-759ba55f0fd7

Reported adverse events (FAERS/openFDA)#

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