Tavaborole

2 DOSAGE AND ADMINISTRATION Apply tavaborole topical solution to affected toenails once daily for 48 weeks. Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated.

Tavaborole topical solution is for topical use only and not for oral, ophthalmic, or intravaginal use. • Apply tavaborole topical solution to affected toenails once daily for 48 weeks. (2) • Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated.

(2) • For topical use only. (2) • Not for oral, ophthalmic, or intravaginal use. (2)

6 ADVERSE REACTIONS Common adverse reactions occurring in ≥1% in subjects treated with tavaborole topical solution included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. gov/medwatch .

1 Clinical Trials Experience 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.

In two clinical trials, 791 subjects were treated with Tavaborole topical solution. The most commonly reported adverse reactions are listed below (Table 1). 2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of Tavaborole topical solution.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug product exposure: Hypersensitivity; contact allergy

4 CONTRAINDICATIONS None. None. (4)