warnings
WARNINGS Ketoconazole cream, 2% is not for ophthalmic use.
FDA label 1a17933e-b9ca-38bf-e063-6294a90a94dd
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
- 9367e7df-b40a-4968-e053-2995a90ae8ac
- SPL ID
- 1a17933e-b9ca-38bf-e063-6294a90a94dd
- Version
- 4
- Effective date
- 2024-06-04
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:44:31
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 | 1a17933e-b9ca-38bf-e063-6294a90a94dd | id | |
| spl set id | 9367e7df-b40a-4968-e053-2995a90ae8ac | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings For extenal use only WHEN USING THIS PRODUCT Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. Flammable Do not use while smoking or near heat or flame DO NOT USE On children under 2 years of age unless directed by a doctor KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away .
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.