BLOOMELLEE 12%GEL AZELAIC ACID ACNE- 12%azelaic acid cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

12%Azelaic Acid

PURPOSE

Acne Cream

INDICATIONS & USAGE

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

For external use only.

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLOOMELLEE 12%GEL AZELAIC ACID ACNE 
12%azelaic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87386-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)	AZELAIC ACID	0.12 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
ALLANTOIN (UNII: 344S277G0Z)
SALICYLIC ACID (UNII: O414PZ4LPZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER (UNII: 2788Z9758H)
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF POWDER (UNII: IJ67X351P9)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYPROPYL .GAMMA.-CYCLODEXTRIN (UNII: P6BYU725IU)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
PANTHENOL (UNII: WV9CM0O67Z)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
FRAGRANCE 13576 (UNII: 5EM498GW35)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
QUATERNIUM-73 (UNII: 5X73DDS97A)
ARGININE (UNII: 94ZLA3W45F)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87386-003-01	1 in 1 BOX	05/25/2026
1		30 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	05/25/2026

Labeler - Shenzhen Lanxi Trading Co., Ltd. (512086574)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Lanxi Trading Co., Ltd.		512086574	manufacture(87386-003)