warnings
WARNINGS ERTACZO ® Cream, 2%, is not indicated for ophthalmic, oral or intravaginal use.
FDA label 6408f1e9-de13-46c4-aa4d-c1ffccf128ef
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
- 07d47bbe-4a4f-4042-8534-d48aa6ce1cd0
- SPL ID
- 6408f1e9-de13-46c4-aa4d-c1ffccf128ef
- Version
- 5
- Effective date
- 2012-12-12
- Source export date
- 2026-10-12
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:22:52
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 | 6408f1e9-de13-46c4-aa4d-c1ffccf128ef | id | |
| spl set id | 07d47bbe-4a4f-4042-8534-d48aa6ce1cd0 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
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adverse reactions
ADVERSE EVENTS In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) patients (2 of them severe) receiving ERTACZO ® Cream, 2%, and in 7 of 291 (2%) patients (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site reaction and skin tenderness. In a dermal sensitization study, 8 of 202 evaluable patients tested with ERTACZO ® Cream, 2%, and 4 of 202 evaluable patients tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers. In non-US post-marketing surveillance for ERTACZO ® Cream, 2%, the following cutaneous adverse events were reported: contact dermatitis, erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.