Drug Facts

Manufacturer
L'Oreal USA Products Inc | Accupac, LLC
Effective date
2025-07-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:59

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication Cleanser
Active ingredientBenzoyl peroxide
Label structure12 sections

Indications and uses

for the treatment of acne helps clear up blemishes and allows skin to heal

Dosage and administration

• apply a dime-size amount to damp skin • gently massage, avoiding the eye area • rinse well • use cleanser on entire affected area, every morning and evening • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 d...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 4.0%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • helps clear up blemishes and allows skin to heal

Warnings

WARNINGS SECTION

For external use only

Do not use if you

OTC - DO NOT USE SECTION

have very sensitive skin
are sensitive to benzoyl peroxide

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
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation becomes severe

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

• apply a dime-size amount to damp skin

• gently massage, avoiding the eye area

• rinse well

• use cleanser on entire affected area, every morning and evening

• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, potassium hydroxide, sodium chloride, sodium citrate, niacinamide, sodium hyaluronate, capryloyl salicylic acid, propanediol, diethylhexyl sodium sulfosuccinate, carbomer, benzoic acid, pentylene glycol, sodium hydroxide, glycolic acid, tetrasodium EDTA, trisodium ethylenediamine disuccinate, citric acid

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

200 ml200 ml200 ml200 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
809316benzoyl peroxide 4 % Medicated Liquid SoapPSN2
809316benzoyl peroxide 40 MG/ML Medicated Liquid SoapSCD2
809316benzoyl peroxide 4 % Topical WashSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-647-01La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication Cleanser200 mL in 1 TUBELIQUID2002
49967-647-02La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication Cleanser1 in 1 CARTONLIQUID12
49967-647-02La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication Cleanser10 mL in 1 TUBELIQUID102

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-64749967-647-01, 49967-647-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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 Dual Action Acne Medication CleanserBENZOYL PEROXIDEL'Oreal USA Products Inccf49ed9b-8c1d-49f9-8c77-bb6a5abce9e42025-07-09WarningsExact identifier
ndc (package): 49967-647-01
ndc (package): 49967-647-02
ndc (product): 49967-647
ndc11 (package): 49967064701
ndc11 (package): 49967064702
spl id: 7e299efe-70fd-4bf7-a5eb-ea4644e4200d
spl set id: cf49ed9b-8c1d-49f9-8c77-bb6a5abce9e4

Reported adverse events (FAERS/openFDA)#

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