Ketoconazole cream, 2%

Ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (BHA), cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol. Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula: Molecular Formula: C 26 H 28 Cl 2 N 4 O 4 Molecular Weight: 531.43 Chemical Structure

Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis. USES Cures most athlete's foot ( tinea pedis) and ringworm (tinea corporis) for effective relief of itchy,scaly skin between the toes.

Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. Seborrheic dermatitis Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. DIRECTIONS clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily for athlete’s foot and ringworm, use daily for 4 weeks if condition persists longer, consult a doctor this product is not effective on scalp or nails.

Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

During clinical trials 45 (5.0%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction. In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely propylene glycol.

Purpose Antifungal

DO NOT USE On children under 2 years of age unless directed by a doctor

WHEN USING THIS PRODUCT Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away .

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

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