FABIOR® is a retinoid in a topical foam formulation for the treatment of acne vulgaris in patients 12 years of age and older. Fabior Foam is not for oral, ophthalmic, or intravaginal use.
Important Safety Information about FABIOR® (tazarotene) Foam
FABIOR® Foam is contraindicated in pregnancy and may cause fetal harm when administered in pregnant women. Females of childbearing potential should have a negative pregnancy test within two weeks prior to initiating treatment and use an effective method of contraception during treatment.It should be used with caution in patients with a history of local tolerability reactions or local hypersensitivity. Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur. Because of increased photosensitivity and risk of sunburn, patients should avoid exposure to sunlight, sunlamps, and weather extremes, and should wear sunscreen daily. The propellant in Fabior Foam is flammable so patients should be instructed to avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions reported at an incidence ≥ 6% are application site irritation, application site dryness, application site erythema, and application site exfoliation.
For additional safety and other information, please see Prescribing Information
To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.