La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment

Manufacturer
COSMETIQUE ACTIVE PRODUCTION
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:57

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment
Active ingredientSALICYLIC ACID
Label structure11 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

shake well before use 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 1.2%

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

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

  • shake well before use
  • 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.

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 68⁰ – 77⁰F
  • protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, azelaic acid, C15-19 alkane, glycerin, triethyl citrate, diglycerin, panthenol, silica, ammonium polyacryloyldimethyl taurate, taraxacum officinale (dandelion) rhizome/root extract, zinc gluconate, glyceryl stearate, PEG-100 stearate, sodium hyaluronate, sodium hydroxide, sodium phosphate, disodium phosphate, hydroxyethylcellulose, hydroxypropyl starch phosphate, tetrasodium glutamate diacetate, citric acid, trisodium ethylenediamine disuccinate, pentylene glycol, polysorbate 60, 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 cartonimage of a cartonimage of a carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69625-735-01La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment1 in 1 CARTONCREAM11
69625-735-01La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment40 mL in 1 BOTTLE, PUMPCREAM401
69625-735-02La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment3 mL in 1 TUBECREAM31
69625-735-02La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment1 in 1 CARTONCREAM11

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69625-73569625-735-01, 69625-735-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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 AZ Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION75e15ed6-e871-4dde-b7fc-145054626fa92025-06-12WarningsExact identifier
ndc (package): 69625-735-02
ndc (package): 69625-735-01
ndc (product): 69625-735
ndc11 (package): 69625073502
ndc11 (package): 69625073501
spl id: 3a5dff13-b7a0-43b8-bc36-f22ced147147
spl set id: 75e15ed6-e871-4dde-b7fc-145054626fa9

Reported adverse events (FAERS/openFDA)#

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