FDA.reportPublic FDA data

KOITE 12% Azelaie Acid Balancing Face Cream

Manufacturer
Guangdong Miaolian Cosmetics Co., Ltd.
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:33

Label at a glance#

ProductKOITE 12% Azelaie Acid Balancing Face Cream
Active ingredientAZELAIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

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

OTC - PURPOSE SECTION

Evens skin tone & fades spots.
Balances oil & prevents breakouts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - ACTIVE INGREDIENT SECTION

AZELAIC ACID ----12%

INACTIVE INGREDIENT SECTION

WATER
PROPYLENE GLYCOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
ETHYLHEXYL PALMITATE
CETEARYL ALCOHOL
CETEARYL GLUCOSIDE
POLYACRYLAMIDE
C13-14 ISOPARAFFIN
LAURETH-7
DIMETHICONE
GLYCERYL STEARATE
PEG-100 STEARATE
SODIUM HYDROXIDE
SODIUM CARBONATE
POLYACRYLATE CROSSPOLYMER-6
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
BUTYLENE GLYCOL
CENTELLA ASIATICA EXTRACT
SCUTELLARIA BAICALENSIS ROOT EXTRACT
POLYGONUM CUSPIDATUM ROOT EXTRACT
CAMELLIA SINENSIS LEAF EXTRACT
KANZOU EKISU
CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT
PENTYLENE GLYCOL
HYDROXYPHENYL PROPAMIDOBENZOIC ACID
METHYLPARABEN
ALLANTOIN
BISABOLOL
PROPYLPARABEN
DIPOTASSIUM GLYCYRRHIZATE
GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT
MENTHA PIPERITA (PEPPERMINT) OIL
DISODIUM EDTA
HYDROXYPROPYL CYCLODEXTRIN
SALICYLIC ACID
ARGININE

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.

DOSAGE & ADMINISTRATION SECTION

When using this product, avoid contact with eyes. If contact occurs,
rinse thoroughly with water. Discontinve use if any irritation or adverse reaction occurs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84507-037-01KOITE 12% Azelaie Acid Balancing Face Cream30 g in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84507-037KOITE 12% AZELAIE ACID BALANCING FACE CREAM (FACE CREAM) CREAM [GUANGDONG MIAOLIAN COSMETICS CO., LTD.]11 package rows20250406_31c7b6f2-9256-8c69-e063-6394a90a749c.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84507-03784507-037-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTYLENE GLYCOL50C1307PZGIACT
ALLANTOIN344S277G0ZIACT
BISABOLOL24WE03BX2TIACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
GLYCYRRHIZA URALENSIS ROOT42B5YD8F0KIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL8LGU7VM393IACT
ETHYLHEXYL PALMITATE2865993309IACT
PEG-100 STEARATEYD01N1999RIACT
SODIUM CARBONATE45P3261C7TIACT
SALICYLIC ACIDO414PZ4LPZIACT
LAURETH-7Z95S6G8201IACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
AZELAIC ACIDF2VW3D43YTACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL STEARATE230OU9XXE4IACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGONUM CUSPIDATUM ROOT7TRV45YZF7IACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE DISODIUM7FLD91C86KIACT
ARGININE94ZLA3W45FIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT2788Z9758HIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CENTELLA ASIATICA ROOT8MXU1P42J0IACT
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
CYCLODEXTRIN7E6SK9QDT8IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
31c7b6f2-9257-8c69-e063-6394a90a749c31c7b6f2-9256-8c69-e063-6394a90a749c2025-04-02WarningsExact identifier
spl id: 31c7b6f2-9257-8c69-e063-6394a90a749c
spl set id: 31c7b6f2-9256-8c69-e063-6394a90a749c

Reported adverse events (FAERS/openFDA)#

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