FDA label b59a2d10-3836-4342-9aba-93024d9fdabb

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
e96ae9cf-e829-466f-b66d-ede83b4d8b3d
SPL ID
b59a2d10-3836-4342-9aba-93024d9fdabb
Version
4
Effective date
2023-10-25
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:46

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS If local infection should continue or become severe, or in the presence of systemic infection, appropriate systemic antibacterial therapy, based on susceptibility testing, should be considered. Because of the concern of nephrotoxicity and ototoxicity associated with neomycin, this combination product should not be used over a wide area or for extended periods of time. There are articles in the current medical literature that indicate an increase in the prevalence of persons sensitive to neomycin.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 3 matching rows.

adverse reactions

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria The following adverse reactions have been reported with the topical use of neomycin: Ototoxicity Nephrotoxicity

adverse reactions table

<table width="80%" styleCode="Noautorules"><col width="32%" align="left" valign="middle"/><col width="34%" align="left" valign="middle"/><col width="34%" align="left" valign="middle"/><tbody><tr><td> Burning</td><td>Hypertrichosis</td><td>Maceration of the skin</td></tr><tr><td> Itching</td><td>Acneiform eruptions</td><td>Secondary infection</td></tr><tr><td> Irritation</td><td>Hypopigmentation</td><td>Skin atrophy</td></tr><tr><td> Dryness</td><td>Perioral dermatitis</td><td>Striae</td></tr><tr><td> Folliculitis</td><td>Allergic contact dermatitis</td><td>Miliaria</td></tr></tbody></table>

adverse reactions table

<table width="80%" styleCode="Noautorules"><col width="32%" align="left" valign="middle"/><col width="68%" align="left" valign="middle"/><tbody><tr><td> Ototoxicity</td><td>Nephrotoxicity</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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