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
- Akron Pharma Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 32b968ce-e112-441c-a91f-c62f2f67b57c
- SPL ID
- 5fbee99b-e93b-4682-9629-98f4f65587fa
- Version
- 3
- Effective date
- 2024-10-20
- Source export date
- 2026-09-28
- 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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:14:16
| 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 | Akron Pharma Inc. | openfda.manufacturer_name | |
| ndc | package | 71399-0666-3 | openfda.package_ndc |
| ndc | package | 71399-0666-6 | openfda.package_ndc |
| ndc | product | 71399-0666 | openfda.product_ndc |
| ndc11 | package | 71399066606 | derived:openfda.package_ndc |
| ndc11 | package | 71399066603 | derived:openfda.package_ndc |
| rxcui | 309370 | openfda.rxcui | |
| spl id | 5fbee99b-e93b-4682-9629-98f4f65587fa | id | |
| spl set id | 32b968ce-e112-441c-a91f-c62f2f67b57c | 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 Akron Pharma, Inc. at 1-877-225-6999 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.