Bloomellee 12%Gel Azelaic Acid Acne

12%AZELAIC ACID TOPICAL HUMAN OTC DRUG

Bloomellee 12%Gel Azelaic Acid Acne is an FDA drug label for the active ingredient 12%AZELAIC ACID manufactured by Shenzhen Lanxi Trading 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 20260525.

Generic name
12%AZELAIC ACID
Manufacturer
Shenzhen Lanxi Trading Co., Ltd.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
87386-003
Application
505G(a)(3)
Label effective
20260525

About this product

Bloomellee 12%Gel Azelaic Acid Acne is an FDA-registered drug product whose active ingredient is 12%AZELAIC ACID. It is labelled by Shenzhen Lanxi Trading Co., Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87386-003, application 505G(a)(3), label effective 20260525. 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 12%AZELAIC ACID are most often described in connection with: clear skin, solution fade, acne marks, soothing oil, control apply, proper amount, night cleansing, massage until. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

12%Azelaic Acid

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.

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.

Warnings

For external use only.

Frequently asked questions

What is Bloomellee 12%Gel Azelaic Acid Acne used for?
Clear Skin Solution Fade Acne Marks Soothing & Oil Control Apply proper amount to facial acne gently after morning and night cleansing, massage until absorbed.

Who makes Bloomellee 12%Gel Azelaic Acid Acne?
Shenzhen Lanxi Trading Co., Ltd. is the labeler of record for Bloomellee 12%Gel Azelaic Acid Acne.

What form does Bloomellee 12%Gel Azelaic Acid Acne 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 Bloomellee 12%Gel Azelaic Acid Acne 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 Bloomellee 12%Gel Azelaic Acid Acne 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.