Clotrimazole and Betamethasone Dipropionate

Clotrimazole and Betamethasone Dipropionate is an FDA-registered drug product whose active ingredient is CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE. It is labelled by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 0168-0258, application ANDA075502, label effective 20260728. It is one of 9 FDA drug label records sharing the active ingredient CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE. 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.

Across FDA labelling, products containing CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE are most often described in connection with: betamethasone dipropionate, cream base, azole antifungal, topical treatment, symptomatic inflammatory, tinea pedis, corporis due, epidermophyton floccosum. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum in patients 17 years and older. Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum in patients 17 years and older. ( 1 )

2 DOSAGE AND ADMINISTRATION Treatment of tinea corporis or tinea cruris: • Apply a thin film of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) into the affected skin areas twice a day for one week. • Do not use more than 45 grams per week. Do not use with occlusive dressings. • If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base), the diagnosis should be reviewed. • Do not use longer than 2 weeks. Treatment of tinea pedis: • Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) into the affected skin areas twice a day for two weeks. • Do not use more than 45 grams per week. Do not use with occlusive dressings. • If a patient shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) the diagnosis should be reviewed. • Do not use longer than 4 weeks. Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. Wash hands after each application. • Tinea pedis : Apply a thin film to the affected skin areas twice a day for 2 weeks. Do not use longer than 4 weeks. ( 2 ) • Tinea cruris and tinea corporis : Apply a thin film to the affected skin area twice a day for 1 week. Do not use longer than 2 weeks. ( 2 ) • Do not use with occlusive dressings unless directed by a physician. ( 2 ) • Not for ophthalmic, oral or intravaginal use. ( 2 )

4 CONTRAINDICATIONS None. • None. ( 4 )

6 ADVERSE REACTIONS Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials common adverse reaction reported for clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency < 1% included rash, edema, and secondary infection. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical corticosteroids: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product). Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products. Adverse reactions reported with the use of clotrimazole are: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin.

FDA lists 9 drug label records with CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE 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.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Clotrimazole and Betamethasone Dipropionate used for?
1 INDICATIONS AND USAGE Clotrimazole and betamethasone dipropionate cream, 1%/0.05% (base) is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum , Trichophyton mentagrophytes , and Trichophyton rubrum in patients 17 years and older. …

Who makes Clotrimazole and Betamethasone Dipropionate?
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC is the labeler of record for Clotrimazole and Betamethasone Dipropionate. 9 FDA label records share the active ingredient CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, 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 and Betamethasone Dipropionate 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 and Betamethasone Dipropionate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE?
Yes. 9 FDA drug label records list CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE 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 and Betamethasone Dipropionate been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.