warnings
WARNINGS: If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
FDA label 16625ecb-11aa-a097-e063-6294a90af3d5
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
- 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
- 2026-11-06
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:54:36
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 |
|---|---|---|---|
| spl id | 16625ecb-11aa-a097-e063-6294a90af3d5 | id | |
| spl set id | 6f7478fa-ed2b-4943-9d40-1fd0161a0854 | set_id |
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.