FDA.reportPublic FDA data

87386-003 Bloomellee 12%Gel Azelaic Acid Acne

Manufacturer
Shenzhen Lanxi Trading Co., Ltd.
Effective date
2026-05-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-zip
Hydrated at
2026-05-27 18:02:34

Label at a glance#

ProductBloomellee 12%Gel Azelaic Acid Acne
Active ingredientAZELAIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

12%Azelaic Acid

OTC - PURPOSE SECTION

Acne Cream

INDICATIONS & USAGE SECTION


Clear Skin Solution
Fade Acne Marks
Soothing & Oil Control
Apply proper amount to facial acne gently after morning and night cleansing, massage until absorbed.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Discontinue use if irritation occurs. If irritation persists, consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: After cleaning your face, apply an appropriate amount of this product to your face and genty massage with your fingertips, focusing on the areas around the pimples until fully absorbed.

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol Glycerin, Niacinamide, Centella Asiatica Leaf Extract, Acrylates/C10-30 Alkyl Acry-late Crosspolymer,Triethanolamine,Panthenol, Phenoxyethanol. Hydroxyacetophenone.Allantoin. Butylene Glycol. Hydroxy-propyl Cyclodextrin, Salicylic Acid, Ethythexyiglycerin, Arginine, Disodium EDTA, PEG-40 Hydrogenated Castor Oll, Centella Asiatica Extract, 1,2-hexanediol, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Fragrance, Quaterni-um-73, Camellia Sinensis Leaf Extract, Kanzou Ekisu. Rosmarinus Officinalls(Rosemary)Leaf Extract, Chamomilla Recutita (Mat-ricaria) Flower Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label2label2

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
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
87386-003-01Bloomellee 12%Gel Azelaic Acid Acne1 in 1 BOXCREAM13
87386-003-01Bloomellee 12%Gel Azelaic Acid Acne30 g in 1 BOTTLE, DROPPERCREAM303

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87386-00387386-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
NIACINAMIDE25X51I8RD4IACT
PEG-40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
ALLANTOIN344S277G0ZIACT
SALICYLIC ACIDO414PZ4LPZIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF POWDERIJ67X351P9IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYPROPYL .GAMMA.-CYCLODEXTRINP6BYU725IUIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
PANTHENOLWV9CM0O67ZIACT
POLYGONUM CUSPIDATUM ROOT7TRV45YZF7IACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
CHAMOMILEFGL3685T2XIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
FRAGRANCE 135765EM498GW35IACT
AZELAIC ACIDF2VW3D43YTACTIB
TRIETHANOLAMINE9O3K93S3TKIACT
QUATERNIUM-735X73DDS97AIACT
ARGININE94ZLA3W45FIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

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
Bloomellee 12%Gel Azelaic Acid Acne12%AZELAIC ACIDShenzhen Lanxi Trading Co., Ltd.529f7394-24fe-1ccd-e063-6394a90a496f2026-05-25WarningsExact identifier
ndc (package): 87386-003-01
ndc (product): 87386-003
ndc11 (package): 87386000301
spl id: 52a1905e-c89c-9dd1-e063-6294a90af10c
spl set id: 529f7394-24fe-1ccd-e063-6394a90a496f

Reported adverse events (FAERS/openFDA)#

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