FDA.reportPublic FDA data

87386-002 Bloomellee 14%Gel Azelaic Acid Cream

Manufacturer
Shenzhen Lanxi Trading Co., Ltd.
Effective date
2026-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-04 05:10:07

Label at a glance#

ProductBloomellee 14%Gel Azelaic Acid Cream
Active ingredientAZELAIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

14%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, Ethylhexyl Palmitate, Glycerin, Cetearyl Alcohol, Mineral Oil, Lauric/myristic/palmitic/stearic Glycerides, Glyceryl Stearate, Butylene Glycol, Totarol, Dimethicone, 0 -cymen-5-ol, PolyacrylamideC13-14 Isoparaffin, Laureth-7, Ceteareth-25, Beeswax, Hydroxyacetophenone, Allantoin, Carbomer, Triethanolamine, Xanthan Gum, Phenoxyethanol, Caprylhydroxamic Acid, Disodium Edta, Fragrance, Dipotassium Glycyrhizate, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Kanzou Ekisu, Chamomila Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf ExtractBacillus/soybean Ferment Extract, Folic Acid, 1,2-hexanediol, Sodium Hyaluronate, Jania Rubens Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

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
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87386-00287386-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
XANTHAN GUMTTV12P4NEEIACT
REYNOUTRIA JAPONICA ROOT7TRV45YZF7IACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYL PALMITATE2865993309IACT
BACILLUS SUBTILIS STRAIN GB033X9V2CJ1MOIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER0A5MM307FCIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF POWDERIJ67X351P9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETEARETH-258FA93U5T67IACT
JANIA RUBENS WHOLEZQ94DKQ7LHIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
WATER059QF0KO0RIACT
TOTAROL67NH2854WWIACT
FRAGRANCE 135765EM498GW35IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYALURONATEYSE9PPT4THIACT
O-CYMEN-5-OLH41B6Q1I9LIACT
GLYCERYL STEARATE230OU9XXE4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
AZELAIC ACIDF2VW3D43YTACTIB
BEESWAX2ZA36H0S2VIACT
TRIETHANOLAMINE9O3K93S3TKIACT
LAURETH-7Z95S6G8201IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
GLYCYRRHIZA GLABRA WHOLEM1F96IE0ZCIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LAURIC/MYRISTIC/PALMITIC/STEARIC GLYCERIDES82TZ9D9546IACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
CHAMOMILEFGL3685T2XIACT
MINERAL OILT5L8T28FGPIACT
FOLIC ACID935E97BOY8IACT

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 14%Gel Azelaic Acid Cream14%AZELAIC ACIDShenzhen Lanxi Trading Co., Ltd.534252e4-9428-4cc7-e063-6394a90ae0fc2026-06-02WarningsExact identifier
ndc (package): 87386-002-01
ndc (product): 87386-002
ndc11 (package): 87386000201
spl id: 534288ee-8c3d-cab9-e063-6294a90a24b6
spl set id: 534252e4-9428-4cc7-e063-6394a90ae0fc

Reported adverse events (FAERS/openFDA)#

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