Clotrimazole antifungal treatment kit

CLOTRIMAZOLE 1% TOPICAL HUMAN OTC DRUG

Clotrimazole antifungal treatment kit is an FDA drug label for the active ingredient CLOTRIMAZOLE 1% 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 1%
Manufacturer
Beautivity LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
85398-012
Application
M005
Label effective
20260629

About this product

Clotrimazole antifungal treatment kit is an FDA-registered drug product whose active ingredient is CLOTRIMAZOLE 1%. It is labelled by Beautivity LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85398-012, application M005, label effective 20260629. It is one of 7 FDA drug label records sharing the active ingredient CLOTRIMAZOLE 1%. 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 1% are most often described in connection with: affected area, cream wash, dry thoroughly, apply thin, twice dally, morning andnight, supervise children, soap wet. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Clotrimazole 1%

Indications & Usage

For cream Wash affected area & dry thoroughly. Apply a thin layer over affected area twice dally (morning andnight). Supervise children in the use of this product. Use daily for 2 weeks. For soap Wet skin with warm water and lather soap. Gently massage onto affected areas. Rinse thoroughly and dry. Use twice daily or as directed by a doctor.

Dosage & Administration

Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tineacorporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Warnings

For external use only. Do not use on children under 2 years of age unless directed by a doctor. avoide contact with eyes, lf contact occurs, rinse thoroughly with water. irritation occurs or if there is no improvement within 2 weeks. lf swallowed, get medical help or contact a Poison Control Center right away.

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How products containing CLOTRIMAZOLE 1% compare

FDA lists 7 drug label records with CLOTRIMAZOLE 1% 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
— — Jiangxi Yudexi Pharmaceutical Co., LTD 2
— — RoyceDerm LLC 2
— — — —
— — — —

Frequently asked questions

What is Clotrimazole antifungal treatment kit used for?
For cream Wash affected area & dry thoroughly. Apply a thin layer over affected area twice dally (morning andnight). Supervise children in the use of this product. Use daily for 2 weeks. For soap Wet skin with warm water and lather soap. Gently massage onto affected areas. Rinse thoroughly and dry. Use twice daily or as directed by a doctor.

Who makes Clotrimazole antifungal treatment kit?
Beautivity LLC is the labeler of record for Clotrimazole antifungal treatment kit. 7 FDA label records share the active ingredient CLOTRIMAZOLE 1%, 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 Clotrimazole antifungal treatment kit 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 Clotrimazole antifungal treatment kit 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 1%?
Yes. 7 FDA drug label records list CLOTRIMAZOLE 1% 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 Clotrimazole antifungal treatment kit 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.