FDA.reportPublic FDA data

10% azelaic acid acne cream

Manufacturer
Guangzhou Ariel Biotech Co., Ltd.
Effective date
2026-03-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:49:14

Label at a glance#

Product10% azelaic acid acne cream
Active ingredientAZELAIC ACID, MADECASSOSIDE, CENTELLA ASIATICA TRITERPENOIDS, LAVANDIN OIL, ASIATICOSIDE, O-CYMEN-5-OL, CAPRYLOYL GLYCINE, HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID, TARAXACUM OFFICINALE LEAF
Label structure12 sections

Dosage and administration

Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use sunscreen during the day.

Storage and handling

No Data

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

AZELAIC ACID 10.00000%

HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID 0.50000%

CAPRYLOYL GLYCINE 0.15000%

o-CYMEN-5-OL 0.09000%

MADECASSOSIDE 0.05500%

CENTELLA ASIATICA EXTRACT 0.03000%

LAVANDULA HYBRIDA OIL 0.03000%

ASIATICOSIDE 0.01500%

SAURURUS CHINENSIS LEAF/ROOT EXTRACT 0.01000%

TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT 0.01000%

STEPHANIA TETRANDRA EXTRACT 0.00160%

Purpose

OTC - PURPOSE SECTION

Acne treatment

①Treatments for acne.
②Reduces acne and blemishes.
③Evens skin tone & fades spots.
④Balances oil & prevents breakouts.

Use

INDICATIONS & USAGE SECTION

Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use
sunscreen during the day.

Warnings

WARNINGS SECTION

WARNINGS:For external use only. avoid the eye area. Avoid direct sunlight during use.
Discontinue use immediately if rritation occurs. Store in a cool, dry place.

Do not use

OTC - DO NOT USE SECTION

Stop using immediately if there is any stimulation

OTC - WHEN USING SECTION

Discontinve use if any irritation or adverse reaction occurs.

OTC - STOP USE SECTION

For external use only, avoid the eye area. Avoid direct sunlight during use. Discontinue use immediately if rritation occurs. Store in a cool, dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer to cleansed face or affected areas morning and evening. Avoid the eye area. Use sunscreen during the day.

Other information

STORAGE AND HANDLING SECTION

No Data

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, AZEL AIC ACID, BUTYLENE GLYCOL, METHYLPROPANEDIOL, DIMETHICONE, CETEARYL GLUCOSIDE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, POLYACRYLATE-6, SQUAL ANE, CETYL ALCOHOL, HYDROXYPROPYL CYCLODEXTRIN, 1,2-HEXANEDIOL, 4-HYDROXYACETOPHENONE, HYDROXYETHYLPIPERAZINEETHANE SULFONIC ACID, STEARYL ALCOHOL, ALLANTOIN, CYCLODEXTRIN, CAPRYLOYL GLYCINE, XANTHAN GUM, O-CYMEN-5-OL, MADECASSOSIDE, CENTELLA ASIATICA EXTRACT, LAVANDULA ANGUSTIFOLIA OL, CENTELLA ASIATICA, SAURURUS CHINENSIS LEAF/ROOT EXTRACT, TARAXACUM OFFICINALE LEAF EXTRACT, STEPHANIA TETRANDRAE EXTRACT

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AZELAIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84148-009-012026-01-29C16284748780-149896155-b05f-586f-e063-e6dba90add9084148-009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84148-009-0110% azelaic acid acne cream30 g in 1 BOTTLECREAM302

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
84148-00984148-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
DIPROPYLENE GLYCOLE107L85C40IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
AZELAIC ACIDF2VW3D43YTACTIB
CETEARYL GLUCOSIDE09FUA47KNAIACT
CYCLODEXTRINS7E6SK9QDT8IACT
ALLANTOIN344S277G0ZIACT
MADECASSOSIDECQ2F5O6YIYACTIB
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JACTIB
LAVANDIN OIL9RES347CKGACTIB
ASIATICOSIDEPKO39VY215ACTIB
O-CYMEN-5-OLH41B6Q1I9LACTIB
CAPRYLOYL GLYCINE8TY5YO42NJACTIB
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACIDRWW266YE9IACTIB
HYDROXYACETOPHENONEG1L3HT4CMHIACT
TARAXACUM OFFICINALE LEAF0022LFJ74YACTIB
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
STEARYL ALCOHOL2KR89I4H1YIACT
XANTHAN GUMTTV12P4NEEIACT
SORBITAN OLIVATEMDL271E3GRIACT
SQUALANEGW89575KF9IACT
DIMETHICONE92RU3N3Y1OIACT

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
10% azelaic acid acne cream10% AZELAIC ACID ACNE CREAMGuangzhou Ariel Biotech Co., Ltd.233ed88c-7e76-f8ad-e063-6394a90aa53e2026-03-06WarningsExact identifier
ndc (package): 84148-009-01
ndc (product): 84148-009
ndc11 (package): 84148000901
spl id: 4c6723a7-8506-44e0-e063-6294a90af299
spl set id: 233ed88c-7e76-f8ad-e063-6394a90aa53e

Reported adverse events (FAERS/openFDA)#

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