KOITE 12% AZELAIE ACID BALANCING FACE CREAM- face cream cream

KOITE 12% Azelaie Acid Balancing Face Cream by

Drug Labeling and Warnings

KOITE 12% Azelaie Acid Balancing Face Cream by is a Otc medication manufactured, distributed, or labeled by Guangdong Miaolian Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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.

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

ACTIVE INGREDIENT

AZELAIC ACID ----12%

INACTIVE INGREDIENT

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

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KOITE 12% AZELAIE ACID BALANCING FACE CREAM 
face cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84507-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)	AZELAIC ACID	12 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ALLANTOIN (UNII: 344S277G0Z)
BISABOLOL (UNII: 24WE03BX2T)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL (UNII: 8LGU7VM393)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM CARBONATE (UNII: 45P3261C7T)
SALICYLIC ACID (UNII: O414PZ4LPZ)
LAURETH-7 (UNII: Z95S6G8201)
MENTHA PIPERITA (PEPPERMINT) OIL (UNII: AV092KU4JH)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ARGININE (UNII: 94ZLA3W45F)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CENTELLA ASIATICA ROOT (UNII: 8MXU1P42J0)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
CYCLODEXTRIN (UNII: 7E6SK9QDT8)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84507-037-01	30 g in 1 TUBE; Type 0: Not a Combination Product	04/02/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/02/2025

Labeler - Guangdong Miaolian Cosmetics Co., Ltd. (707598469)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Miaolian Cosmetics Co., Ltd.		707598469	label(84507-037) , manufacture(84507-037)