Ketoconazole Cream 20 mg/g
Ketoconazole Cream · CREAM · Direct_Rx
Ketoconazole cream is a prescription antifungal medication applied directly to the skin to treat fungal infections. It works by stopping the growth of fungi that cause conditions like ringworm, athlete's foot, and other skin fungal infections.
Key Facts
- Brand Name
- Ketoconazole Cream
- Generic Name
- Ketoconazole Cream
- NDC Code (Product)
72189-422- Manufacturer
- Direct_Rx
- Strength
- 20 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA212443
- Drug Class
- Azole Antifungal [EPC]
- Marketing Start
- 02/07/2023
Recall History
Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Fougera Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Full Prescribing Information
Indications & Usage
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); and in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
Dosage & Administration
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. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Seborrheic dermatitis: Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until no clinical clearing. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
Warnings
Ketoconazole Cream, 2% is not for ophthalmic use. Ketoconazole Cream, 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Contraindications
Ketoconazole Cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Adverse Reactions
During clinical trials 45 (5%) 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 sodium sulfite or propylene glycol. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Ketoconazole Cream used for?
Ketoconazole cream is a prescription antifungal medication applied directly to the skin to treat fungal infections. It works by stopping the growth of fungi that cause conditions like ringworm, athlete's foot, and other skin fungal infections.
Is Ketoconazole Cream a controlled substance?
Ketoconazole Cream is not classified as a controlled substance by the DEA.
What is the generic name for Ketoconazole Cream?
The generic name for Ketoconazole Cream is Ketoconazole Cream. There are 8 other brand versions of Ketoconazole Cream.
What is the NDC code for Ketoconazole Cream 20 mg/g?
The NDC (National Drug Code) for Ketoconazole Cream 20 mg/g is 72189-422, listed by Direct_Rx.