warnings
WARNINGS: If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
Crotan
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
- Crotan
- Generic name
- CROTAMITON
- Manufacturer
- Marnel Pharmaceuticals, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 6f7478fa-ed2b-4943-9d40-1fd0161a0854
- SPL ID
- 16625ecb-11aa-a097-e063-6294a90af3d5
- Version
- 11
- Effective date
- 2024-04-18
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:24:15
| 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 | 087204 | derived:openfda.application_number |
| application number | ANDA087204 | openfda.application_number | |
| brand name | Crotan | openfda.brand_name | |
| generic name | CROTAMITON | openfda.generic_name | |
| manufacturer name | Marnel Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 0682-0051-10 | openfda.package_ndc |
| ndc | package | 0682-0051-30 | openfda.package_ndc |
| ndc | package | 0682-0051-20 | openfda.package_ndc |
| ndc | product | 0682-0051 | openfda.product_ndc |
| ndc11 | package | 00682005110 | derived:openfda.package_ndc |
| ndc11 | package | 00682005120 | derived:openfda.package_ndc |
| ndc11 | package | 00682005130 | derived:openfda.package_ndc |
| rxcui | 106219 | openfda.rxcui | |
| rxcui | 2049603 | openfda.rxcui | |
| spl id | 16625ecb-11aa-a097-e063-6294a90af3d5 | id | |
| spl set id | 6f7478fa-ed2b-4943-9d40-1fd0161a0854 | set_id | |
| unii | D6S4O4XD0H | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Rx ONLY
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Primary irritation reactions such as dermatitis, pruritus and rash, and allergic sensitivity reactions have been reported in a few patients. To report SUSPECTED ADVERSE REACTIONS, contact Marnel Pharmaceuticals at 1-888-850-2905 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.