Usual Adult Dose for Onychomycosis - Toenail

Apply to affected toenail(s) once a day for 48 weeks.

Comments:

• The integrated flow-through brush applicator should be used.
• The toenail, toenail folds, toenail bed, hyponychium, and undersurface of the toenail plate should be completely covered.

Usual Pediatric Dose for Onychomycosis - Toenail

6 years or older: Apply to affected toenail(s) once a day for 48 weeks.

Comments:

• The integrated flow-through brush applicator should be used.
• The toenail, toenail folds, toenail bed, hyponychium, and undersurface of the toenail plate should be completely covered.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For topical use only; not for oral, ophthalmic, or intravaginal use
• Apply to clean, dry toenails; wait at least 10 minutes after showering, bathing, or washing before applying.

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Keep away from heat or flame; do not freeze.
• Keep bottle closed tightly; store upright.

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Do not use near heat or open flame; product is flammable.
• Use on affected toenails and immediately adjacent skin only.
• Consult healthcare professional if application area shows signs of persistent irritation (e.g., redness, itching, swelling).
• The impact of nail polish or other cosmetic nail products on the efficacy of this drug has not been established.