warnings
WARNINGS CLOTRIMAZOLE TOPICAL SOLUTION is not for ophthalmic use.
Clotrimazole
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
- Clotrimazole
- Generic name
- CLOTRIMAZOLE
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- c64e2290-593f-48a2-a15d-41689f836fda
- SPL ID
- c64e2290-593f-48a2-a15d-41689f836fda
- Version
- 1
- Effective date
- 2026-07-16
- Source export date
- 2026-10-30
- 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/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 18:36:04
| 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 | 074580 | derived:openfda.application_number |
| application number | ANDA074580 | openfda.application_number | |
| brand name | Clotrimazole | openfda.brand_name | |
| generic name | CLOTRIMAZOLE | openfda.generic_name | |
| manufacturer name | Preferred Pharmaceuticals Inc. | openfda.manufacturer_name | |
| ndc | package | 68788-4155-3 | openfda.package_ndc |
| ndc | product | 68788-4155 | openfda.product_ndc |
| ndc11 | package | 68788415503 | derived:openfda.package_ndc |
| rxcui | 309370 | openfda.rxcui | |
| spl id | c64e2290-593f-48a2-a15d-41689f836fda | id | |
| spl set id | c64e2290-593f-48a2-a15d-41689f836fda | set_id | |
| unii | G07GZ97H65 | 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 The following adverse reactions have been reported in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritius, urticaria, burning, and general irritation of the skin.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.