10% Azelaic Acid
10% Azelaic Acid is an FDA drug label for the active ingredient AZELAIC ACID CREAM manufactured by Guangzhou Ariel Medical Technology Co., Ltd. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260703.
- Generic name
- AZELAIC ACID CREAM
- Manufacturer
- Guangzhou Ariel Medical Technology Co., Ltd.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 87815-002
- Application
- M006
- Label effective
- 20260703
About this product
10% Azelaic Acid is an FDA-registered drug product whose active ingredient is AZELAIC ACID CREAM. It is labelled by Guangzhou Ariel Medical Technology Co., Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87815-002, application M006, label effective 20260703. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing AZELAIC ACID CREAM are most often described in connection with: treatment acne. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
For the treatment of acne.
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).
Warnings
For external use only.
Frequently asked questions
What is 10% Azelaic Acid used for?
For the treatment of acne.
Who makes 10% Azelaic Acid?
Guangzhou Ariel Medical Technology Co., Ltd. is the labeler of record for 10% Azelaic Acid.
What form does 10% Azelaic Acid come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is 10% Azelaic Acid prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has 10% Azelaic Acid been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.