Dosage & Administration
Directions
Cleanse face to remove dirt and impurities.
Wash face and gently pat dry.
Dispense cream onto hands and apply directly to acne-prone areas.
Use twice daily (morning and evening).
10% Azelaic Acid Cream
FDA Label NDC 87815-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ariel Medical Technology Co., Ltd. for the product 10% Azelaic Acid (NDC 87815-002). 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 dosage & administration, indications & usage, otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
For the treatment of acne.
Otc - Active Ingredient
Azelaic Acid 10%
Otc - Purpose
Acne Treatment
Warnings
For external use only.
Otc - Do Not Use
on broken skin; if allergic to any ingredients.
Otc - Ask Doctor
Ask a doctor before use if: pregnant or nursing, or have any underlying medical condition.
Otc - When Using
When using this product: avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if: significant facial swelling, large areas of red rash, intense itching or burning sensation.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children: if swallowed, get medical help or contact Poison Control Center right away.
Other Safety Information
Store at room temperature (10°C–25°C). Do not expose to temperatures above 45°C. Keep away from light.
Inactive Ingredient
Water, Butylene Glycol, Methylpropandiol, Dimethicone, Cetearyl Glucoside, Dipropylene Glycol, Sorbitan Olivate, Polyacrylate-6, Squalane, Cetyl Alcohol, Hydroxypropyl Cyclodextrin, 1,2-Hexanediol, 4-Hydroxyacetophenone, Hydroxyethylpiperazineethan Sulfate, Allantoin, Cyclodextrin, Caprylyl Glycine, Xanthan Gum, O-Cymene-5-ol, Madecassoside, Centella Asiatica Extract, Lavandula Angustifolia Oil, Centella Asiatica, Saurus Chinensis Leaf/Root Extract, Taraxacum Officinale Leaf Extract, Stephania Tetrandrae Extract.
Other
Distributed by: Ariel Biotech Inc
1226 NORTH KING ST.NUM 968
WILMINGTON, DE 19801
USA
* Please review the disclaimer below.
