openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS • EXTINA ® Foam may result in contact sensitization, including photoallergenicity ( 5.1 , 6.2 ). • The contents of EXTINA ® Foam are flammable ( 5.2 ). 5.1 Contact Sensitization EXTINA ® Foam may result in contact sensitization, including photoallergenicity. [See Adverse Reactions ( 6.2 )] 5.2 Flammable Contents The contents of EXTINA ® Foam include alcohol and propane/butane, which are flammable. Avoid fire, flame and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C). 5.3 Systemic Effects Hepatitis has been seen with orally administered ketoconazole (1:10,000 reported incidence). Lowered testosterone and ACTH–induced corticosteroid serum levels have been seen with high doses of orally administered ketoconazole. These effects have not been seen with topical ketoconazole.
6 ADVERSE REACTIONS The most common adverse reactions observed in clinical studies (incidence > 1%) were application site burning and application site reaction ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Stiefel Laboratories, Inc. at 1-888-784-3335 (STIEFEL) or adverse.event@stiefel.com and FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates. The safety data presented in Table 1 (below) reflect exposure to EXTINA ® Foam in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied EXTINA ® Foam or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Adverse reactions occurring in > 1% of subjects are presented in Table 1. Table 1: Adverse Reactions Reported by > 1% Subjects in Clinical Trials Adverse Reactions EXTINA ® Foam N = 672 n (%) Vehicle Foam N = 497 n (%) Subjects with an Adverse Reaction 188 (28%) 122 (25%) Application site burning 67 (10%) 49 (10%) Application site reaction 41 (6%) 24 (5%) Application site reactions that were reported in < 1% of subjects were dryness, erythema, irritation, paresthesia, pruritus, rash and warmth. 6.2 Dermal Safety Studies In a photoallergenicity study, 9 of 53 subjects (17%) had reactions during the challenge period at both the irradiated and non-irradiated sites treated with EXTINA ® Foam. EXTINA ® Foam may cause contact sensitization.