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.
Koite 12% Azelaie Acid Balancing Face Cream
FDA Label NDC 84507-037
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Miaolian Cosmetics Co., Ltd. for the product Koite 12% Azelaie Acid Balancing Face Cream (NDC 84507-037). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, otc - purpose, otc - keep out of reach of children, otc - active ingredient, inactive ingredient, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Evens skin tone & fades spots.
Balances oil & prevents breakouts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - 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.
Package Label.Principal Display Panel
Package (12)
* Please review the disclaimer below.
