RoyceDerm Tea Tree Oil Antifungal .spray.

CLOTRIMAZOLE 1% TOPICAL HUMAN OTC DRUG

RoyceDerm Tea Tree Oil Antifungal .spray. is an FDA drug label for the active ingredient CLOTRIMAZOLE 1% manufactured by RoyceDerm 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 20260528.

Generic name
CLOTRIMAZOLE 1%
Manufacturer
RoyceDerm LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
85424-024
Application
M005
Label effective
20260528

About this product

RoyceDerm Tea Tree Oil Antifungal .spray. is an FDA-registered drug product whose active ingredient is CLOTRIMAZOLE 1%. It is labelled by RoyceDerm LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85424-024, application M005, label effective 20260528. 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, athlete foot, dry thoroughly, spray thin, twice daily, night directed, doctor supervise, payspecial attention. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Clotrimazole 1%

Indications & Usage

Clean the affected area and dry thoroughly. Spray a thin layer of the product over affected area twice daily(morning and night), or as directed by a doctor. Supervise children in the useof this product. For Athlete's foot: payspecial attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks atleast once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult adoctor. This product is not effective on the scalp or nails.

Warnings

For external use only When using this product Avoid contact with the eye. Stop and ask a doctor if irritation occurs or ifthere is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot & righworm. Do not use on children under 2 of age except under the advice ad supervision of a doctor. If 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 RoyceDerm Tea Tree Oil Antifungal .spray. used for?
Clean the affected area and dry thoroughly. Spray a thin layer of the product over affected area twice daily(morning and night), or as directed by a doctor. Supervise children in the useof this product. For Athlete's foot: payspecial attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks atleast once daily. For athlete's foot and ringworm, use …

Who makes RoyceDerm Tea Tree Oil Antifungal .spray.?
RoyceDerm LLC is the labeler of record for RoyceDerm Tea Tree Oil Antifungal .spray.. 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 RoyceDerm Tea Tree Oil Antifungal .spray. 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 RoyceDerm Tea Tree Oil Antifungal .spray. 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 RoyceDerm Tea Tree Oil Antifungal .spray. 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.