FDA label
What is clotrimazole used for?
The FDA-approved uses of clotrimazole, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur.”
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Clotrimazole Topical Solution Usp, 1%, solution
Indications and Usage, quoted from the label by ScieGen Pharmaceuticals, Inc (ANDA216569). Cross-references to other label sections are left out.
Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur.
This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton fluoccosum, and Microsporum canis.
Source: DailyMed label, set id 15368c2a-572f-41fb-a3a1-7b1eb842faa8, version 6, effective April 30, 2026. NDC 50228-502, one of 8 listings for this product.
Clotrimazole, cream
Indications and Usage, quoted from the label by Redpharm Drug (ANDA090219). Cross-references to other label sections are left out.
Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur.
Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.
Source: DailyMed label, set id 53cafc9f-7761-83a9-e063-6294a90a3437, version 1, effective June 9, 2026. NDC 67296-2252, one of 5 listings for this product.
Clotrimazole, lozenge
Indications and Usage, quoted from the label by Rising Pharma Holdings, Inc. (ANDA215641). Cross-references to other label sections are left out.
Clotrimazole Lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment.
Clotrimazole Lozenges are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION.)
Source: DailyMed label, set id 980736aa-751a-4642-ab85-a309435fd02f, version 2, effective March 27, 2025. NDC 16571-686, one of 3 listings for this product.
Questions
What is clotrimazole used for?
The FDA label says: “Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicansand tinea versicolor due to Malassezia furfur.”
What drug class is clotrimazole?
FDA lists clotrimazole in the Azole Antifungal established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Clotrimazole
- Is Clotrimazole a controlled substance?Federal schedule
- Generic for LotriminFDA Orange Book
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- Generic for CloticFDA Orange Book
- Azole Antifungals listFDA drug class
- NDC 15370-220Clotrimazole NDC record
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- NDC 0574-0107Clotrimazole NDC record