FDA label 4635a059-1d0d-4f98-b6ff-272ecb6d4f2d

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: 093ed88b-9451-49a7-a23a-5ff9e7ab15ab
SPL ID: 4635a059-1d0d-4f98-b6ff-272ecb6d4f2d
Version: 2
Effective date: 2012-05-13
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:33:51

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		4635a059-1d0d-4f98-b6ff-272ecb6d4f2d	id
spl set id		093ed88b-9451-49a7-a23a-5ff9e7ab15ab	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 Warning For External Use Only Do not use In the eye for more than 4 days Ask a doctor before use if you have ear drainage or discharge pain, irritation or rash in the ear had ear surgery an injury or perforation (hole) in the ear drum Stop use and ask a doctor if Stop use and ask a doctor if excessive earwax remains after use Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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