FDA label 618083ab-73e1-1a00-e053-2a91aa0a1ccd

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: 4b601252-9b3b-4022-83b4-ca437254e4d9
SPL ID: 618083ab-73e1-1a00-e053-2a91aa0a1ccd
Version: 3
Effective date: 2017-12-29
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:13:23

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		618083ab-73e1-1a00-e053-2a91aa0a1ccd	id
spl set id		4b601252-9b3b-4022-83b4-ca437254e4d9	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 Do not use • if you have ear drainage or discharge, ear pain, irritation or rash in the ear or are dizzy; consult a doctor • if you have an injury or perforation (hole) of the ear drum or after ear surgery, unless directed by a doctor • for more than 4 consecutive days; if excessive earwax remains after use of this product, consult a doctor When using this product • avoid contact with eyes. If accidental contact with eyes occurs, flush eyes with water and consult a doctor Keep out of reach of the children If product is 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.