warnings
WARNINGS: If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
Pruradik
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
- Pruradik
- Generic name
- CROTAMITON
- Manufacturer
- Trifluent Pharma, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3699175f-bfc8-a047-e063-6394a90a80d1
- SPL ID
- 36991086-14b5-9e66-e063-6394a90ad654
- Version
- 1
- Effective date
- 2025-06-02
- Source export date
- 2026-10-12
- 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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:53:52
| 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 | Pruradik | openfda.brand_name | |
| generic name | CROTAMITON | openfda.generic_name | |
| manufacturer name | Trifluent Pharma, LLC | openfda.manufacturer_name | |
| ndc | package | 73352-051-10 | openfda.package_ndc |
| ndc | product | 73352-051 | openfda.product_ndc |
| ndc11 | package | 73352005110 | derived:openfda.package_ndc |
| rxcui | 106219 | openfda.rxcui | |
| spl id | 36991086-14b5-9e66-e063-6394a90ad654 | id | |
| spl set id | 3699175f-bfc8-a047-e063-6394a90a80d1 | 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 Trifluent Pharma, LLC at 1-888-927-5191 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.