Home FDA labels 6094e3c6-ba85-4774-a61d-233f92b92c6c FDA label 6094e3c6-ba85-4774-a61d-233f92b92c6c 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 02b6cc3c-3aec-47dc-8936-fdc7ce8bdb55
SPL ID 6094e3c6-ba85-4774-a61d-233f92b92c6c
Version 5
Effective date 2011-09-26
Source export date 2026-10-12
Source partition 6
Source file https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:48:52 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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warnings WARNINGS 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 Made in Italy For additional information visit www.luxiq.com Questions: Call 1-888-784-3335 (1-888-STIEFEL). Side effects should be reported to this number. P/N: LUXIQ is a registered trademark of Stiefel Laboratories, Inc. ©2011 Stiefel Laboratories, Inc. LXQ:1PI
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adverse reactions ADVERSE REACTIONS The most frequent adverse event was burning/itching/stinging at the application site; the incidence and severity of this event were as follows: Incidence and severity of burning/itching/stinging Maximum severity Product Total incidence Mild Moderate Severe Luxíq Foam n=63 34 (54%) 28 (44%) 5 (8%) 1 (2%) Betamethasone valerate lotion n=63 33 (52%) 26 (41%) 6 (10%) 1 (2%) Placebo Foam n=32 24 (75%) 13 (41%) 7 (22%) 4 (12%) Placebo Lotion n=30 20 (67%) 12 (40%) 5 (17%) 3 (10%) Other adverse events which were considered to be possibly, probably, or definitely related to Luxíq occurred in 1 patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
adverse reactions table <table> <col width="36%"/> <col width="17%"/> <col width="11%"/> <col width="11%"/> <col width="10%"/> <tbody> <tr> <td align="center" colspan="5" styleCode="Botrule Toprule " valign="top"> <paragraph>Incidence and severity of burning/itching/stinging</paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule " valign="top"/> <td styleCode="Rrule Botrule " valign="top"/> <td align="center" colspan="3" styleCode="Botrule " valign="top"> <paragraph>Maximum severity</paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>Product</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>Total incidence</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>Mild</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>Moderate</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph>Severe</paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>Luxíq Foam n=63</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>34 (54%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>28 (44%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>5 (8%)</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph>1 (2%)</paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>Betamethasone valerate lotion n=63</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>33 (52%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>26 (41%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>6 (10%)</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph>1 (2%)</paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>Placebo Foam n=32</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>24 (75%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>13 (41%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>7 (22%)</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph>4 (12%)</paragraph> </td> </tr> <tr> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>Placebo Lotion n=30</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>20 (67%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>12 (40%)</paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>5 (17%)</paragraph> </td> <td align="center" styleCode="Botrule " valign="top"> <paragraph>3 (10%)</paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.