Composition
- Active ingredients
- CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- CLOTRIMAZOLE 1% · SolutionNDA018181-002 · Over the counter
- CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SolutionThis page
- CLOTRIMAZOLE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · Troche/lozengeNDA018713-001 · Discontinued
- CLOTRIMAZOLE 1% · CreamNDA018183-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA018181.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Mycelex
- Active substance
- clotrimazole
- Route
- Topical
- Dosage form
- Solution
- Applicant
- Bayer Hlthcare
- Status
- Discontinued
- FDA approval
- 15 Jan 1979
- Application
- NDA018181-001