Tinea Versicolor Treatment Bar

CLOTRIMAZOLE TOPICAL HUMAN OTC DRUG

Tinea Versicolor Treatment Bar is an FDA drug label for the active ingredient CLOTRIMAZOLE manufactured by Beautivity 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 20260629.

Generic name
CLOTRIMAZOLE
Manufacturer
Beautivity LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
85398-003
Application
M005
Label effective
20260629

About this product

Tinea Versicolor Treatment Bar is an FDA-registered drug product whose active ingredient is CLOTRIMAZOLE. It is labelled by Beautivity LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85398-003, application M005, label effective 20260629. It is one of 39 FDA drug label records sharing the active ingredient CLOTRIMAZOLE. 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 CLOTRIMAZOLE are most often described in connection with: helps relieve, prevent itching, burning cracking, scaling associated, tinea versicolor. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

coltrimazole 1%

Indications & Usage

Helps relieve and prevent itching, burning, cracking, and scaling associated with tinea versicolor infections.

Dosage & Administration

Wash the affected area thoroughly and allow the product to sit for 1-2 minutes before rinsing. Ensure the affected area is dried completely. Apply 1-2 times daily for 4 weeks. This product is not effective for use on the scalp or nails.

Warnings

For external use only Do not use on Children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes, if contact occurs, rinse thoroughly with water. Stop use and ask doctor if irritation occurs or if there is no improvement within 2 weeks. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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How products containing CLOTRIMAZOLE compare

FDA lists 39 drug label records with CLOTRIMAZOLE 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 formProductsManufacturerProducts
— — Beautivity LLC 3
— — YYBA CORP 3
— — Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 2
— — Proficient Rx LP 2
— — A-S Medication Solutions 1

Frequently asked questions

What is Tinea Versicolor Treatment Bar used for?
Helps relieve and prevent itching, burning, cracking, and scaling associated with tinea versicolor infections.

Who makes Tinea Versicolor Treatment Bar?
Beautivity LLC is the labeler of record for Tinea Versicolor Treatment Bar. 39 FDA label records share the active ingredient CLOTRIMAZOLE, 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 Tinea Versicolor Treatment Bar 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 Tinea Versicolor Treatment Bar 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 CLOTRIMAZOLE?
Yes. 39 FDA drug label records list CLOTRIMAZOLE 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 Tinea Versicolor Treatment Bar 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.