warnings
Warnings For external use only, do not inject. Do not use if seal is broken or missing in case of ear infection, eardrum perforation, or if there is a foreign body in the ear without consulting physician in case of any type of earache
FDA label f546bbbf-a2e3-21f9-e053-2a95a90a1016
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
- 467bad22-2fd7-4009-907e-165168607882
- SPL ID
- f546bbbf-a2e3-21f9-e053-2a95a90a1016
- Version
- 2
- Effective date
- 2023-02-22
- Source export date
- 2026-10-30
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/0b630a6825fc0c8abba22d7c8fd4d069bde78bef928766047ddbb369119f337f/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 18:56:20
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 | f546bbbf-a2e3-21f9-e053-2a95a90a1016 | id | |
| spl set id | 467bad22-2fd7-4009-907e-165168607882 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.