warnings
WARNINGS Clotrimazole cream USP 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
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 77883cfd-f13c-40cb-88b2-8f777e1cdce9
- SPL ID
- 3e748b32-1a66-10b0-e063-6394a90a7321
- Version
- 8
- Effective date
- 2025-09-10
- Source export date
- 2026-10-12
- 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/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:28:49
| 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 | 072640 | derived:openfda.application_number |
| application number | ANDA072640 | openfda.application_number | |
| brand name | Clotrimazole | openfda.brand_name | |
| generic name | CLOTRIMAZOLE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 51672-1275-1 | openfda.package_ndc |
| ndc | package | 51672-1275-6 | openfda.package_ndc |
| ndc | package | 51672-1275-7 | openfda.package_ndc |
| ndc | package | 51672-1275-2 | openfda.package_ndc |
| ndc | product | 51672-1275 | openfda.product_ndc |
| ndc11 | package | 51672127507 | derived:openfda.package_ndc |
| ndc11 | package | 51672127502 | derived:openfda.package_ndc |
| ndc11 | package | 51672127506 | derived:openfda.package_ndc |
| ndc11 | package | 51672127501 | derived:openfda.package_ndc |
| rxcui | 309367 | openfda.rxcui | |
| spl id | 3e748b32-1a66-10b0-e063-6394a90a7321 | id | |
| spl set id | 77883cfd-f13c-40cb-88b2-8f777e1cdce9 | 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 this product: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, burning, and general irritation of the skin. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-866-923-4914 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.