ANTI-DANDRUFF
ANTI-DANDRUFF is an FDA drug label for the active ingredient KETOCONAZOLE manufactured by Guangzhou ChuanMa International 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 20260905.
- Generic name
- KETOCONAZOLE
- Manufacturer
- Guangzhou ChuanMa International Trading Co.,Ltd.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 85593-128
- Application
- M032
- Label effective
- 20260905
About this product
ANTI-DANDRUFF is an FDA-registered drug product whose active ingredient is KETOCONAZOLE. It is labelled by Guangzhou ChuanMa International Trading Co.,Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85593-128, application M032, label effective 20260905. It is one of 17 FDA drug label records sharing the active ingredient KETOCONAZOLE. 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 KETOCONAZOLE are most often described in connection with: best results, steps carefully, lukewarm water, wet hair, scalp thoroughly, applya sufficient, amount shampooto, generate rich. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
For best results, follow these steps carefully:lukewarm water. 1.Wet hair and scalp thoroughly with 2.Applya sufficient amount of shampooto generate a rich lather.3.Gently massage the lather into your scalp and hair. 4.Leave the lather on the scalp for 3-5medication to work effectively.5.Rinse thoroughly with water. minutes. This contact time is crucialfor the
Dosage & Administration
Use every 3-4 days for up to 8 weeks. Afterthat, use only asneeded to control dandruff.
Warnings
For external use only. Avoid contact witheyes. Ifcontact occurs, rinse thoroughlywithwater.
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View labelHow products containing KETOCONAZOLE compare
FDA lists 17 drug label records with KETOCONAZOLE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Guangzhou ChuanMa International Trading Co.,Ltd. | 4 |
| — | — | A-S Medication Solutions | 3 |
| — | — | Proficient Rx LP | 2 |
| — | — | Amerisyn LLC | 1 |
| — | — | Burel Pharmaceuticals, LLC | 1 |
Recall and safety notices
2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0734-2016 | sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654 | J. Strickland and Co | Class III | Terminated | 20160309 |
| D-0318-2015 | sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray, Active Ingredient: Salicylic Acid, 2%, 12 FL OZ (356ml) spray bottle, OTC, Made in the U.S.A. J. Strickland & Co., OLIVE BRANCH, MS 38654 UPC: 0 7561044510 7 | J. Strickland and Co | Class III | Terminated | 20141231 |
Frequently asked questions
What is ANTI-DANDRUFF used for?
For best results, follow these steps carefully:lukewarm water. 1.Wet hair and scalp thoroughly with 2.Applya sufficient amount of shampooto generate a rich lather.3.Gently massage the lather into your scalp and hair. 4.Leave the lather on the scalp for 3-5medication to work effectively.5.Rinse thoroughly with water. minutes. This contact time is crucialfor the
Who makes ANTI-DANDRUFF?
Guangzhou ChuanMa International Trading Co.,Ltd. is the labeler of record for ANTI-DANDRUFF. 17 FDA label records share the active ingredient KETOCONAZOLE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does ANTI-DANDRUFF 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 ANTI-DANDRUFF 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.
Are there other products containing KETOCONAZOLE?
Yes. 17 FDA drug label records list KETOCONAZOLE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has ANTI-DANDRUFF been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
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.