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
- Proficient Rx LP
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 4f08caf2-a57c-4146-9289-532711bbdbcd
- SPL ID
- b8de64ec-7114-42c5-a6c6-ee1122b05bf9
- Version
- 5
- Effective date
- 2022-04-01
- Source export date
- 2026-11-06
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:31:15
| 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 | Proficient Rx LP | openfda.manufacturer_name | |
| ndc | package | 63187-774-30 | openfda.package_ndc |
| ndc | package | 63187-774-60 | openfda.package_ndc |
| ndc | package | 63187-774-15 | openfda.package_ndc |
| ndc | product | 63187-774 | openfda.product_ndc |
| ndc11 | package | 63187077415 | derived:openfda.package_ndc |
| ndc11 | package | 63187077430 | derived:openfda.package_ndc |
| ndc11 | package | 63187077460 | derived:openfda.package_ndc |
| rxcui | 203088 | openfda.rxcui | |
| spl id | b8de64ec-7114-42c5-a6c6-ee1122b05bf9 | id | |
| spl set id | 4f08caf2-a57c-4146-9289-532711bbdbcd | 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.