Drug Facts

Manufacturer
L'Oreal USA Products Inc | COSMETIQUE ACTIVE PRODUCTION
Effective date
2025-06-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:02:25

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment
Active ingredientSALICYLIC ACID
Label structure10 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 if going outside, apply ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 0.5%

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

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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, dimethicone, isocetyl stearate, niacinamide, isopropyl lauroyl sarcosinate, silica, ammonium polyacryloyldimethyl taurate, oryza sativa (rice) starch, punica granatum pericarp extract, potassium cetyl phosphate, sorbitan oleate, zinc PCA, glyceryl stearate SE, isohexadecane, sodium hydroxide, myristyl myristate, 2-oleamido-1,3-octadecanediol, mannose, poloxamer 338, propanediol, hydroxyethoxyphenyl butanone, capryloyl salicylic acid, caprylyl glycol, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, maltodextrin, xanthan gum, pentylene glycol, polysorbate 80, acrylamide/sodium acryloyldimethyltaurate copolymer, piroctone olamine, 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 descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199308salicylic acid 0.5 % Topical SolutionPSN2
199308salicylic acid 5 MG/ML Topical SolutionSCD2
199308salicylic acid 0.5 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-926-01La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment1 in 1 CARTONLIQUID12
49967-926-01La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment40 mL in 1 TUBELIQUID402
49967-926-02La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment3 mL in 1 TUBELIQUID32
49967-926-02La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment1 in 1 CARTONLIQUID12

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-92649967-926-01, 49967-926-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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 Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incb36837e3-ea1c-41db-b52c-4175100895292025-06-05WarningsExact identifier
ndc (package): 49967-926-02
ndc (package): 49967-926-01
ndc (product): 49967-926
ndc11 (package): 49967092602
ndc11 (package): 49967092601
spl id: 12a4edea-21cf-4b60-99e9-29541cb92f3d
spl set id: b36837e3-ea1c-41db-b52c-417510089529

Reported adverse events (FAERS/openFDA)#

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