INDIVIDUAL ARTICLE: Topical Corticosteroid Approved Labeling in the US: A Modern Inter- and Intra-Product Analysis
November 2026 | Volume 25 | Issue 11 | 10424s11 | Copyright © November 2026
Published online September 18, 2026
Adam J. Friedman MDa, Lawrence F. Eichenfield MDb, Mark Boguniewicz MDc, Elaine C. Siegfried MDd, Douglas DiRuggiero DMSce, Lisa Weiss MMScf, Melissa S. Seal PhDg, Brett Stephenson PharmDg, Raja Mikkili MAg, Robert C. Higham MPASg, Diane Hanna DNP DCNP FAANPg, Alexandra K. Golant MDh
aGeorge Washington School of Medicine and Health Sciences, Washington, DC
bDepartments of Dermatology and Pediatrics, University of California San Diego-School of Medicine and Rady Children's Hospital, San Diego, CA
cNational Jewish Health, Denver and University of Colorado School of Medicine, Aurora, CO
dDivision of Pediatric Dermatology, Saint Louis University School of Medicine, St. Louis, MO
eSkin Cancer and Cosmetic Dermatology Center, Rome, GA
fGoodman Dermatology, Canton, GA
gArcutis Biotherapeutics, Inc., Westlake Village, CA
hIcahn School of Medicine at Mount Sinai, New York, NY
Abstract
Background: A wide variety of prescription-strength topical corticosteroids (TCS) have been commercially available for many decades. Product labels often vary, reflecting inconsistent guidance for dosing, duration of use, and safety.
Objective: This study was designed to analyze and compare dosing and safety information among TCS product labels approved by the United States (US) Food and Drug Administration (FDA).
Methods: The FDA's openFDA Public Label API was used to collect US TCS labels. The content of each label was searched for safety terminology and quantitative use limits. These data were assessed for consistency across products.
Results: Warnings for a variety of adverse events (AEs) were found in TCS labels including, but not limited to, allergic contact dermatitis, skin infections, hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing syndrome, cataracts and glaucoma, and carcinogenesis. However, none of these warnings were included in all labels and were inconsistent among labels for the same active ingredient. Recommended limits on treatment duration and total weekly dose were included in some labels (35% and 22%, respectively) but many had no limits. If TCS are applied as described in the labels, patients with ~15% or greater affected body surface area will exceed weekly dose limits for HPA axis suppression.
Conclusions: FDA-approved product labels are intended to inform clinical decision support systems. TCS product labels unfortunately do not contain warnings for known AEs and have inconsistent or absent dosing recommendations. Lack of guidance and inconsistent safety information diminish awareness of the risks associated with long-term use and/or overuse of these medications and can impact access. TCS label review and revision are warranted to eliminate inconsistency, modernize language around warnings and precautions, and provide clear dosing instructions and exposure limits to better inform clinicians, patients, and caregivers about safe use of these medications.
INTRODUCTION
Topical corticosteroids (TCS) have been prescribed for over 70 years by a number of medical specialties to treat a range of inflammatory dermatoses.1,2 These drugs have evolved to include a variety of formulations across a wide spectrum of potencies, each with exposure-related risks impacting safe treatment durations, dose limits, and application sites.2-5
Cutaneous (eg, barrier compromise, atrophy, striae, dyspigmentation) and systemic (eg, adrenal insufficiency, cataracts) TCS adverse events (AEs) are well documented.2-5 The risks increase with overuse from prolonged, frequent, and/or widespread application, application under occlusion, use of higher-than-necessary potencies, and concomitant use of multiple formulations for differing indications. Use of high-potency TCS on high-risk sites (eg, face and skin folds) carries an increased risk of percutaneous absorption and associated systemic AEs. These risks are greater for children.2
