Finished product reference
Clotrimazole
Cream · Topical · 1 % · 15 g
- List code
- 326
- Pharmacologic class
- Azole Antifungal
Indications
INDICATIONS & USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and 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 .
Dosage and administration (summary)
DOSAGE & ADMINISTRATION Gently massage sufficient Clotrimazole Topical Solution, USP 1% into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritus, usually occurs within the first week of treatment with Clotrimazole Topical Solution, USP 1%. If the patient shows no clinical improvement after 4 weeks of treatment with Clotrimazole Topical Solution, USP 1% the diagnosis should be reviewed.
Contraindications
CONTRAINDICATIONS Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Warnings and precautions
WARNINGS Clotrimazole Topical Solution is not for ophthalmic use.
Pregnancy
Usage in Pregnancy Teratogenic Effects Pregnancy Category B The disposition of 14 C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans.
Storage and supply
HOW SUPPLIED Clotrimazole Topical Solution, USP 1% is supplied as follows: NDC 70954-036-20 in 30 mL one bottle in a carton Store at 2° to 30°C (36° to 86°F). Manufactured by: Novitium Pharma LLC 70 Lake Drive East Windsor, New Jersey 08520 LB-4008-01 Revised:12/18
Source: Clotrimazole Topical (Clotrimazole) — US FDA prescribing information, 2020-08-13, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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