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
- ScieGen Pharmaceuticals, Inc
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 15368c2a-572f-41fb-a3a1-7b1eb842faa8
- SPL ID
- 50b252b4-beb8-3d5a-e063-6394a90a3490
- Version
- 6
- Effective date
- 2026-04-30
- Source export date
- 2026-10-12
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:39:08
| 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 | 216569 | derived:openfda.application_number |
| application number | ANDA216569 | 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 | ScieGen Pharmaceuticals, Inc | openfda.manufacturer_name | |
| ndc | package | 50228-502-08 | openfda.package_ndc |
| ndc | package | 50228-502-30 | openfda.package_ndc |
| ndc | package | 50228-502-31 | openfda.package_ndc |
| ndc | package | 50228-502-61 | openfda.package_ndc |
| ndc | product | 50228-502 | openfda.product_ndc |
| ndc11 | package | 50228050231 | derived:openfda.package_ndc |
| ndc11 | package | 50228050261 | derived:openfda.package_ndc |
| ndc11 | package | 50228050230 | derived:openfda.package_ndc |
| ndc11 | package | 50228050208 | derived:openfda.package_ndc |
| rxcui | 309370 | openfda.rxcui | |
| spl id | 50b252b4-beb8-3d5a-e063-6394a90a3490 | id | |
| spl set id | 15368c2a-572f-41fb-a3a1-7b1eb842faa8 | 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. To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.