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
- NORTHSTAR RX LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- bf3e48fd-e063-42e6-acd1-580ddc6e93be
- SPL ID
- 494f72d9-37d0-5066-e063-6394a90a95bc
- Version
- 3
- Effective date
- 2026-01-26
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:19:00
| 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 | NORTHSTAR RX LLC | openfda.manufacturer_name | |
| ndc | package | 16714-955-01 | openfda.package_ndc |
| ndc | package | 16714-955-02 | openfda.package_ndc |
| ndc | package | 16714-955-03 | openfda.package_ndc |
| ndc | product | 16714-955 | openfda.product_ndc |
| ndc11 | package | 16714095502 | derived:openfda.package_ndc |
| ndc11 | package | 16714095501 | derived:openfda.package_ndc |
| ndc11 | package | 16714095503 | derived:openfda.package_ndc |
| rxcui | 203088 | openfda.rxcui | |
| spl id | 494f72d9-37d0-5066-e063-6394a90a95bc | id | |
| spl set id | bf3e48fd-e063-42e6-acd1-580ddc6e93be | 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. To report SUSPECTED ADVERSE REACTIONS, contact Northstar RxLLC at 1-800-206-7821 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.