Drug Facts

Manufacturer
L’Oreal USA Products Inc | Beauty Manufacturing Solutions Corp.
Effective date
2026-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:59

Label at a glance#

ProductLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPO
Active ingredientBENZOYL PEROXIDE
Label structure13 sections

Indications and uses

for the treatment of acne 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 mayoccur, start with one application daily, thengradually increase to two or three timesdaily if needed or as directed by a doctor if bothersome dryness or peeling occurs,reduce application to once a day or everyother day if going outside, apply sunsc...

Storage and handling

store at room temperature 68°-77°F

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 5.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • clears acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes from forming

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

  • 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 mayoccur, start with one application daily, thengradually increase to two or three timesdaily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs,reduce application to once a day or everyother day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 68°-77°F

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, pentylene glycol, carbomer, silica, tocopheryl acetate, sodium citrate, sodium hydroxide, sodium metabisulfite, diethylhexyl sodium sulfosuccinate, phenoxyethanol, epilobium angustifolium flower/leaf/stem extract, propanediol, acrylates/C10-30 alkyl acrylate
crosspolymer, disodium EDTA, potassium hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-LRP LABO 1-888-577-5226
Monday -Friday (9 a.m .- 5p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 ml Tube20 ml Tube20 ml carton20 ml carton3 ml Tube3 ml Tube15 3 ml Carton15 3 ml Carton40 ml Tube40 ml Tube40 ml Carton40 ml Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
597667benzoyl peroxide 5.5 % Topical CreamPSN1
597667benzoyl peroxide 55 MG/ML Topical CreamSCD1
597667benzoyl peroxide 5.5 % Topical CreamSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133606000654884GTIN-13: 3606000654884
EAN-13: 3606000654884
GTIN storage (14 digits): 03606000654884
20ml carton.jpg
QR code linkQR Codelr.oaqr.io/01/0360600065220015 3ml.jpg
QR code linkQR Codelr.oaqr.io/01/0360600065488420ml carton.jpg

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
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82046-884-01LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPO20 mL in 1 TUBECREAM201
82046-884-01LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPO1 in 1 CARTONCREAM11
82046-884-02LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPO15 in 1 CARTONCREAM151
82046-884-02LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPO3 mL in 1 TUBECREAM31
82046-884-03LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPO1 in 1 CARTONCREAM11
82046-884-03LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE BENZOYL PEROXIDE EFFACLAR BPO40 mL in 1 TUBECREAM401

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82046-88482046-884-01, 82046-884-02, 82046-884-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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 BENZOYL PEROXIDE EFFACLAR BPOBENZOYL PEROXIDELOreal USA Products Inc851882ac-56f4-4bf6-b942-6efea10eec3e2026-05-26WarningsExact identifier
ndc (package): 82046-884-02
ndc (package): 82046-884-03
ndc (package): 82046-884-01
ndc (product): 82046-884
ndc11 (package): 82046088402
ndc11 (package): 82046088401
ndc11 (package): 82046088403
spl id: 52bb7505-a02a-2533-e063-6294a90a2520
spl set id: 851882ac-56f4-4bf6-b942-6efea10eec3e

Reported adverse events (FAERS/openFDA)#

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