Miconazole Nitrate is an over-the-counter medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Brand names
- Kopa Haiku Antifungal Cream, Medline, Anti-Fungal Powder, Antifungal, Athletes Foot, Folliculitis Treatment Cream, Jock Itch Powder, Lotrimin AF Jock Itch, ProCure Antifungal
- Taken
- Topical
- Label
- Guangzhou ChuanMa International Trading Co.,Ltd., revised October 3, 2026 · full label on DailyMed
Purpose
treats most athlete's foot (tinea pedis), jockitch (tinea cruris), and ringworm(tinea corporis)relieves itching, scaling, cracking, burning,redness, soreness, irritation, and discomfortassociated with these conditions
What it is used for
Stop use and askadoctor if irritation occurs or if there is no improvement within 4 weeks for athlete's foot and ringworm-irritation occurs or if there is no improvementwithin 2 weeks for jock itch
Active ingredient
Miconazole Nitrate 2% PurposeAntifungal
Warnings
For external use only. Donotusebyadoctor · on children under 2 years of age unless directed
Keep out of reach of children
Keep outofreach of children.If swallowed, get medical help or contact aPoison Control Center right away.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Miconazole in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
Reason: Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Lots, distribution and details
- Product
- Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
- Lots / codes
- Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025
- Distribution
- Nationwide in the USA
- Quantity
- 1,786 tubes
- Recall started
- January 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0315-2024
-
Class II Terminated
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 533…
Reason: CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Lots, distribution and details
- Product
- Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79
- Lots / codes
- Lot 007782, Exp 08/31/2024
- Distribution
- Nationwide
- Quantity
- —
- Recall started
- October 4, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0091-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Miconazole Nitrate
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 5ced6af9-f9c4-6e62-e063-6294a90a0e11.