FDA label 7bd5c6a7-7a80-1432-e053-2991aa0a60a4

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 (canonical bytes are SHA-256 checked before publication)

SPL set ID: 9fadec5a-dedd-471b-8551-65fd73b5cf7f
SPL ID: 7bd5c6a7-7a80-1432-e053-2991aa0a60a4
Version: 4
Effective date: 2018-11-29
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 02:23:34

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		7bd5c6a7-7a80-1432-e053-2991aa0a60a4	id
spl set id		9fadec5a-dedd-471b-8551-65fd73b5cf7f	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Keep away from eyes. Do not take by mouth. Earache drops are only to be used in the ears. Tip of applicator should not enter ear canal. As with any drug, ask a doctor before use if pregnant or breastfeeding. Consult a physician if: Symptoms persist for more than 48 hours Discharge from the ear is present Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately In case of emergency, contact a medical professional or Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.