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
- NuCare Pharmaceuticals,Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 570acb82-0c6f-0b98-e054-00144ff8d46c
- SPL ID
- 2a321ff6-d67f-0fca-e063-6394a90a8644
- Version
- 6
- Effective date
- 2024-12-26
- Source export date
- 2026-08-08
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-08/f9914d64bdcd01a4629905fd6421fbe60196ad98c430d1a297f4114fa869f148/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
- Import run
- 20260810T161303Z
- Imported at
- 2026-08-10 16:21:12
| 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 | NuCare Pharmaceuticals,Inc. | openfda.manufacturer_name | |
| ndc | package | 68071-1709-3 | openfda.package_ndc |
| ndc | product | 68071-1709 | openfda.product_ndc |
| ndc11 | package | 68071170903 | derived:openfda.package_ndc |
| rxcui | 203088 | openfda.rxcui | |
| spl id | 2a321ff6-d67f-0fca-e063-6394a90a8644 | id | |
| spl set id | 570acb82-0c6f-0b98-e054-00144ff8d46c | 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.