medicated
medicated is an FDA drug label for the active ingredient MICONAZOLE manufactured by Nabrace LLC 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 20260416.
- Generic name
- MICONAZOLE
- Manufacturer
- Nabrace LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 84056-002
- Application
- M005
- Label effective
- 20260416
About this product
medicated is an FDA-registered drug product whose active ingredient is MICONAZOLE. It is labelled by Nabrace LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84056-002, application M005, label effective 20260416. It is one of 5 FDA drug label records sharing the active ingredient MICONAZOLE. 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 MICONAZOLE are most often described in connection with: hand sanitizer, help reduce, cause disease. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Dosage & Administration
Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Warnings
Warnings For external use only. Flammable. Keep away from heat or flame
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View labelHow products containing MICONAZOLE compare
FDA lists 5 drug label records with MICONAZOLE 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 |
|---|---|---|---|
| — | — | Nabrace LLC | 2 |
| — | — | Natouch LLC | 1 |
| — | — | Unifirst First Aid Corporation | 1 |
| — | — | VIVE HEALTH LLC | 1 |
| — | — | — | — |
Recall and safety notices
5 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-0790-2026 | Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205. | Church & Dwight Co., Inc. | Class II | Ongoing | 20260902 |
| D-0095-2026 | ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25 | Church & Dwight Co., Inc. | Class II | Ongoing | 20251029 |
| D-0504-2025 | ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5 | Church & Dwight Inc | Class I | Ongoing | 20250709 |
| D-0418-2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatment 0.7 fl. oz. (20 mL: UPC 883140035275) Tube, (benzoyl peroxide 0.5% and benzoyl peroxide 5.5% and salicylic acid 2%), La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France, UPC 883140035282 (kit). | L'Oreal USA | Class II | Ongoing | 20250521 |
| D-0066-2025 | THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1 | Unexo Life Sciences Private Limited | Class II | Terminated | 20241204 |
Frequently asked questions
What is medicated used for?
Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Who makes medicated?
Nabrace LLC is the labeler of record for medicated. 5 FDA label records share the active ingredient MICONAZOLE, 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 medicated 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 medicated 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 MICONAZOLE?
Yes. 5 FDA drug label records list MICONAZOLE 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 medicated been recalled?
5 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.