warnings
WARNINGS Clotrimazole topical solution is not for ophthalmic use.
Clotrimazole Topical Solution USP, 1%
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 Topical Solution USP, 1%
- Generic name
- CLOTRIMAZOLE TOPICAL SOLUTION USP, 1%
- Manufacturer
- TruPharma LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 1d2354f2-edfd-4be7-9550-760958eb36ee
- SPL ID
- 48ab26b2-908a-43d1-e063-6394a90a2cb5
- Version
- 5
- Effective date
- 2026-01-18
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:15:49
| 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 | 212281 | derived:openfda.application_number |
| application number | ANDA212281 | openfda.application_number | |
| brand name | Clotrimazole Topical Solution USP, 1% | openfda.brand_name | |
| generic name | CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% | openfda.generic_name | |
| manufacturer name | TruPharma LLC | openfda.manufacturer_name | |
| ndc | package | 52817-800-30 | openfda.package_ndc |
| ndc | product | 52817-800 | openfda.product_ndc |
| ndc11 | package | 52817080030 | derived:openfda.package_ndc |
| rxcui | 309370 | openfda.rxcui | |
| spl id | 48ab26b2-908a-43d1-e063-6394a90a2cb5 | id | |
| spl set id | 1d2354f2-edfd-4be7-9550-760958eb36ee | 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.