Oxistat 10 mg/mL
oxiconazole nitrate · LOTION · ANI Pharmaceuticals, Inc.
Oxistat is a lotion containing oxiconazole nitrate at 10 mg/mL, taken topical. Manufactured by ANI Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Oxistat
- Generic Name
- oxiconazole nitrate
- NDC Code (Product)
62559-285- Manufacturer
- ANI Pharmaceuticals, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- LOTION
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA020209
- Marketing Start
- 09/12/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE OXISTAT Lotion is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ).
Dosage & Administration
DOSAGE AND ADMINISTRATION OXISTAT Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Tinea corporis and tinea cruris should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.
Warnings
WARNINGS OXISTAT (oxiconazole nitrate) Lotion, 1% is for topical use only and not for oral, ophthalmic or intravaginal use.
Contraindications
CONTRAINDICATIONS OXISTAT Lotion is contraindicated in individuals who have shown hypersensitivity to any of their components.
Drug Interactions
Drug Interactions Potential drug interactions between OXISTAT and other drugs have not been systematically evaluated.
Adverse Reactions
ADVERSE REACTIONS In a controlled, multicenter clinical trial of 269 patients treated with oxiconazole nitrate lotion , 1%, 7 (2.6%) reported adverse reactions thought to be related to drug therapy. These reactions included burning and stinging (0.7% each) and pruritus, scaling, tingling, pain, and dyshidrotic eczema (0.4% each). The following additional adverse experiences have been reported with the topical use of oxiconazole nitrate: irritation and allergic contact dermatitis, folliculitis, erythema, papules, fissure, maceration, rash, and nodules. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Oxistat used for?
Oxistat contains oxiconazole nitrate. It is a lotion taken topical. Consult your doctor for specific uses.
Is Oxistat a controlled substance?
Oxistat is not classified as a controlled substance by the DEA.
What is the generic name for Oxistat?
The generic name for Oxistat is oxiconazole nitrate. There are 2 other brand versions of oxiconazole nitrate.
What is the NDC code for Oxistat 10 mg/mL?
The NDC (National Drug Code) for Oxistat 10 mg/mL is 62559-285, listed by ANI Pharmaceuticals, Inc..