FDA label 38ac49a4-36b4-47ec-b141-d63991e8b770

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
52633127-7c36-451a-b6de-30a70a367f30
SPL ID
38ac49a4-36b4-47ec-b141-d63991e8b770
Version
2
Effective date
2020-05-06
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:11

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep tube tightly closed. If irritation develops, the use of Hydrocortisone 1% – Iodoquinol 1% Cream should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. If extensive areas are treated or if the occlusive technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if iodoquinol is present in the diaper or urine. Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy.

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. These reactions are listed in an approximate decreasing order of occurrence: Burning Perioral dermatitis Itching Allergic contact dermatitis Irritation Maceration of the skin Dryness Secondary infection Folliculitis Skin atrophy Hypertrichosis Striae Acneiform eruptions Miliaria Hypopigmentation

adverse reactions table

<table width="65%" styleCode="Noautorules"> <col width="10%" align="left" valign="top"/> <col width="40%" align="left" valign="top"/> <col width="50%" align="left" valign="top"/> <tbody> <tr> <td/> <td>Burning</td> <td>Perioral dermatitis</td> </tr> <tr> <td/> <td>Itching</td> <td>Allergic contact dermatitis</td> </tr> <tr> <td/> <td>Irritation</td> <td>Maceration of the skin</td> </tr> <tr> <td/> <td>Dryness</td> <td>Secondary infection</td> </tr> <tr> <td/> <td>Folliculitis</td> <td>Skin atrophy</td> </tr> <tr> <td/> <td>Hypertrichosis</td> <td>Striae</td> </tr> <tr> <td/> <td>Acneiform eruptions</td> <td>Miliaria</td> </tr> <tr> <td/> <td>Hypopigmentation</td> <td/> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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