warnings
WARNINGS OXISTAT ® (oxiconazole nitrate cream)Cream, 1% and OXISTAT ® (oxiconazole nitrate lotion) Lotion, 1% are not for ophthalmic or intravaginal use.
FDA label 0b5b9f06-15fc-432d-a891-8d91bf80f2d4
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 094d5b1e-ccf6-4384-b208-fd70360ffda2
- SPL ID
- 0b5b9f06-15fc-432d-a891-8d91bf80f2d4
- Version
- 1
- Effective date
- 2009-10-30
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:29:21
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 0b5b9f06-15fc-432d-a891-8d91bf80f2d4 | id | |
| spl set id | 094d5b1e-ccf6-4384-b208-fd70360ffda2 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS During clinical trials, of 955 patients treated with oxiconazole nitrate cream , 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each). 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).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.