Home FDA labels 7a3f76ec-3c2f-4a29-92a0-68cd8e1ce066 FDA label 7a3f76ec-3c2f-4a29-92a0-68cd8e1ce066 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 3dab9411-df12-4073-9cc1-3273e2aee7e7
SPL ID 7a3f76ec-3c2f-4a29-92a0-68cd8e1ce066
Version 1
Effective date 2010-06-29
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 01:26:11 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 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. Coral Gables, FL 33134 USA For additional information visit www.luxiq.com Questions? Call 1-888-500-DERM (3376). Side effects may be reported to this number. 303203 P/N: xxxxxxxx Lixuq, VersaFoam-HF, VersaFoam-HF & Design, Stiefel, and Stiefel & Design are registered trademarks of Stiefel Laboratories, Inc. ©2009 Stiefel Laboratories, Inc. Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK 74146
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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 border="none" width="368.000" ID="id_f0a4cde9-f0b6-4da6-9341-d2ca59ae9468"> <col width="25.8%"/> <col width="26.6%"/> <col width="16.3%"/> <col width="14.9%"/> <col width="16.3%"/> <tbody> <tr ID="id_68a0885e-a331-4f8d-b76d-84694e2ac86c"> <td align="left" valign="top" colspan="5">Incidence and severity of burning/itching/stinging</td> </tr> <tr ID="id_e3188182-4cf6-482e-a3ff-b55907a27f0c"> <td align="left" valign="top"/> <td align="left" valign="top"/> <td align="left" valign="top" colspan="3">Maximum severity</td> </tr> <tr ID="id_2eeaf046-e55a-40db-9743-317a839585f2"> <td align="left" valign="top" rowspan="2">Product</td> <td align="left" valign="top" rowspan="2">Total incidence</td> <td align="left" valign="top" rowspan="2">Mild</td> <td align="left" valign="top" rowspan="2">Moderate</td> <td align="left" valign="top">Severe</td> </tr> <tr ID="id_a4ebbc89-1d1f-40b4-b7fc-41cd8afdcb79"> <td align="left" valign="top"/> </tr> <tr ID="id_478187ce-6bb5-4bbc-9a78-f0ed34d90340"> <td align="left" valign="top">Luxíq Foam n=63</td> <td align="left" valign="top">34 (54%)</td> <td align="left" valign="top">28 (44%)</td> <td align="left" valign="top">5 (8%)</td> <td align="left" valign="top">1 (2%)</td> </tr> <tr ID="id_7ee79ca0-6b5c-4d45-855e-5062e2839222"> <td align="left" valign="top" rowspan="2">Betamethasone valerate lotion n=63</td> <td align="left" valign="top" rowspan="2">33 (52%)</td> <td align="left" valign="top" rowspan="2">26 (41%)</td> <td align="left" valign="top" rowspan="2">6 (10%)</td> <td align="left" valign="top">1 (2%)</td> </tr> <tr ID="id_ed780e98-3846-4e66-8423-eb95ecf162d4"> <td align="left" valign="top"/> </tr> <tr ID="id_fc02980f-b134-4d7b-88fb-aec0e1b6f3eb"> <td align="left" valign="top">Placebo Foam n=32</td> <td align="left" valign="top">24 (75%)</td> <td align="left" valign="top">13 (41%)</td> <td align="left" valign="top">7 (22%)</td> <td align="left" valign="top">4 (12%)</td> </tr> <tr ID="id_cbd1af5d-ce1a-41a4-9452-6be0340b2256"> <td align="left" valign="top" styleCode="Botrule">Placebo Lotion n=30</td> <td align="left" valign="top" styleCode="Botrule">20 (67%)</td> <td align="left" valign="top" styleCode="Botrule">12 (40%)</td> <td align="left" valign="top" styleCode="Botrule">5 (17%)</td> <td align="left" valign="top" styleCode="Botrule">3 (10%)</td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.