warnings
WARNINGS Ketoconazole cream, 2% is not for ophthalmic use.
Ketoconazole
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
- Brand name
- Ketoconazole
- Generic name
- KETOCONAZOLE
- Manufacturer
- A-S Medication Solutions
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 8ef1117d-0b63-4c26-beaa-7667b2387e14
- SPL ID
- 9fe63a1b-7944-4b27-bd49-288fcb59eccd
- Version
- 3
- Effective date
- 2023-11-17
- 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 05:32:09
| Harmonized routes |
|---|
| TOPICAL |
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 |
|---|---|---|---|
| application applno | ANDA | 075638 | derived:openfda.application_number |
| application number | ANDA075638 | openfda.application_number | |
| brand name | Ketoconazole | openfda.brand_name | |
| generic name | KETOCONAZOLE | openfda.generic_name | |
| manufacturer name | A-S Medication Solutions | openfda.manufacturer_name | |
| ndc | package | 50090-6069-0 | openfda.package_ndc |
| ndc | product | 50090-6069 | openfda.product_ndc |
| ndc11 | package | 50090606900 | derived:openfda.package_ndc |
| rxcui | 203088 | openfda.rxcui | |
| spl id | 9fe63a1b-7944-4b27-bd49-288fcb59eccd | id | |
| spl set id | 8ef1117d-0b63-4c26-beaa-7667b2387e14 | set_id | |
| unii | R9400W927I | openfda.unii |
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 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.