FDA records indicate that there are no current recalls for this drug.
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A4100-17 Continuous Epidural 17g Tuohy Recall
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Questions & Answers
Side Effects & Adverse Reactions
Ketoconazole cream, 2% is not for ophthalmic use.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula:
Molecular Formula: C26H28Cl2N4O4
Molecular Weight: 531.43
Sources
A4100-17 Continuous Epidural 17g Tuohy Manufacturers
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Smiths Medical Asd, Inc.
A4100-17 Continuous Epidural 17g Tuohy | Preferred Pharmaceuticals, Inc.
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolorIt 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 dermatitisKetoconazole 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.
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