FDA.reportPublic FDA data

Avene Cleanance Acne Medicated Clearing Gel Cleanser

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:35:15

Label at a glance#

ProductAvene Cleanance Acne Medicated Clearing Gel Cleanser
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

For the treatment of acne.

Dosage and administration

Apply morning and evening on a skin previously moistened with water. Gently massage, avoiding the eye area. Rinse thoroughly then dry.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Acne Medication

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne.

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.

When using this product

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 morning and evening on a skin previously moistened with water.

Gently massage, avoiding the eye area.

Rinse thoroughly then dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), sodium cocoyl isethionate, cocamidopropyl hydroxysultaine, propanediol, stearyl alcohol, coco-glucoside, sodium lauroyl sarcosinate, betaine, glyceryl laurate, sodium chloride, glycerin, cetearyl olivate, hydroxypropyl methylcellulose, sodium benzoate, saccharide isomerate, sorbitan olivate, hydroxypropyl guar hydroxypropyltrimonium chloride, xanthan gum, trisodium ethylenediamine disuccinate, potassium sorbate, lactobacillus ferment lysate, citric acid, sodium citrate, acrylates copolymer

Questions or comments?

OTC - QUESTIONS SECTION

Visit www.aveneusa.com or call toll-free

1-866-41-AVENE (28363)

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EAU THERMALE

Avene

LABORATORIE DERMATOLOGIQUE

CLEANANCE

ACNE

MEDICATED CLEARING GEL CLEANSER

ACNE MEDICATED GEL CLEANER [SALICYLIC ACID 2%]

FOR OILY, ACNE-PRONE, SENSITIVE SKIN

FACE AND BODY

HELPS CLEAR AND PREVENT NEW ACNE BLEMISHES AND BLACKHEADS.

MAINTAINS A HEALTHY, BALANCED SKIN.

200 ML

6.7 FL. OZ.

Avene Cleanance Acne Medicated Clearing Gel CleanserAvene Cleanance Acne Medicated Clearing Gel Cleanser

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64760-775-01Avene Cleanance Acne Medicated Clearing Gel Cleanser25 mL in 1 TUBELIQUID252
64760-775-01Avene Cleanance Acne Medicated Clearing Gel Cleanser1 in 1 CARTONLIQUID12
64760-775-02Avene Cleanance Acne Medicated Clearing Gel Cleanser1 in 1 CARTONLIQUID12
64760-775-02Avene Cleanance Acne Medicated Clearing Gel Cleanser200 mL in 1 TUBELIQUID2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-775AVENE CLEANANCE ACNE MEDICATED CLEARING GEL CLEANSER (SALICYLIC ACID) LIQUID [PIERRE FABRE USA INC.]2Current NDC, 4 package rows20241108_faa8e2b6-5204-5f1a-e053-6294a90a65f7.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64760-77564760-775-01, 64760-775-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPANEDIOL5965N8W85TIACT
CETEARYL OLIVATE58B69Q84JOIACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
COCO GLUCOSIDEICS790225BIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
BETAINE3SCV180C9WIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
SORBITAN OLIVATEMDL271E3GRIACT
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)3A1I7376TCIACT
XANTHAN GUMTTV12P4NEEIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
SODIUM CHLORIDE451W47IQ8XIACT

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
Avene Cleanance Acne Medicated Clearing Gel CleanserSALICYLIC ACIDPierre Fabre USA Inc.faa8e2b6-5204-5f1a-e053-6294a90a65f72024-11-06WarningsExact identifier
ndc (package): 64760-775-02
ndc (package): 64760-775-01
ndc (product): 64760-775
ndc11 (package): 64760077502
ndc11 (package): 64760077501
spl id: 26442ac7-c774-283b-e063-6394a90a1a75
spl set id: faa8e2b6-5204-5f1a-e053-6294a90a65f7

Reported adverse events (FAERS/openFDA)#

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