FDA.reportPublic FDA data

FDA label 367518ef-8e24-4823-8b29-78002f88aee7

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
1eb217be-34f1-4b3b-a3a5-4dfb83fb6143
SPL ID
367518ef-8e24-4823-8b29-78002f88aee7
Version
3
Effective date
2020-01-31
Source export date
2026-10-12
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/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:27:06

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 Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence beginning with column 1: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria

adverse reactions table

<table width="60%" styleCode="Noautorules"> <col width="50%" align="left" valign="top"/> <col width="50%" align="left" valign="top"/> <tbody> <tr> <td>Burning</td> <td>Hypertrichosis</td> </tr> <tr> <td>Maceration of the skin</td> <td>Itching</td> </tr> <tr> <td>Acneiform eruptions</td> <td>Secondary infection</td> </tr> <tr> <td>Irritation</td> <td>Hypopigmentation</td> </tr> <tr> <td>Skin atrophy</td> <td>Dryness</td> </tr> <tr> <td>Perioral dermatitis</td> <td>Striae</td> </tr> <tr> <td>Folliculitis</td> <td>Allergic contact dermatitis</td> </tr> <tr> <td>Miliaria</td> <td/> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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