FDA label c5337d48-36f3-47ec-bd06-f7f7c8b65c0c

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
797805f2-5a08-4ed3-8057-6b0b1bb08113
SPL ID
c5337d48-36f3-47ec-bd06-f7f7c8b65c0c
Version
1
Effective date
2012-05-02
Source export date
2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:04:10

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNING FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C). Manufactured for Stiefel Laboratories, Inc. Research Triangle Park, NC 27709 For additional information: 1-888-784-3335 (STIEFEL) or visit www.olux.com OLX:1PI OLUX is a registered trademark of Stiefel Laboratories, Inc. ©2011 Stiefel Laboratories, Inc. March 2011 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of Olux Foam therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with Olux Foam. (See Table 3 below.) Table 3: Subjects with reversible HPA axis suppression at any time during treatment Dermatosis Olux Foam Psoriasis 1 of 9 Atopic Dermatitis 4 of 4 Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients (see PRECAUTIONS ). In a controlled clinical trial (188 subjects) with Olux Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the Olux Foam treated subjects. In two controlled clinical trials (360 subjects) with Olux Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the Olux Foam treated subjects included application site burning (10%), application site dryness (< 1%), and other application site reactions (4%). In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%). The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as Olux Foam. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.

adverse reactions table

<table border="single" width="225.000" ID="id_44875b7e-2e75-4f80-ba9a-c918c6b05551"> <caption ID="id_ae7f0814-0c34-4fb5-aa13-d8546c66f7b8">Table 3: Subjects with reversible HPA axis suppression at any time during treatment</caption> <col width="56.0%"/> <col width="44.0%"/> <tbody> <tr ID="id_2f5a24e8-4a7d-41d1-80c4-a60c26e9b3f1"> <td align="left" valign="top" styleCode="Botrule Toprule Rrule Lrule">Dermatosis</td> <td align="center" valign="top" styleCode="Botrule Rrule">Olux Foam</td> </tr> <tr ID="id_1be6f426-83bd-47d9-989a-fea30f5235d1"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Psoriasis</td> <td align="center" valign="top" styleCode="Botrule Rrule">1 of 9</td> </tr> <tr ID="id_e42410e9-183a-449f-a36b-8501b3095784"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Atopic Dermatitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">4 of 4</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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