Poly-ureaurethane is a biocompatible, polymeric solution that is applied topically to the nails. It Poly-ureaurethane coats and adheres to the nail surface, providing a flexible, waterproof barrier film that protects against the effects of moisture, abrasion, and friction, thus improving fragile, splitting nails (nail dystrophy). It may be used for intact or damaged nails. The film wears off naturally and must be re-applied as directed to be effective.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
Other Topical Formulations
Topical Nail Solution
-Apply in a well-ventilated area away from open flames and sources of ignition as the solution is flammable.
-Do not use other products, ointments, creams or lotions on the treated area as this may prevent the film from forming correctly.
-Dip applicator into solution and wipe off excess on lip of bottle.
-Apply in even strokes to entire affected nail plate, proximal and lateral folds, and the distal tip.
-Allow to dry completely before applying pads or clothing.
-Cleanse the affected nails with nail polish remover once a week.
-Contact of the solution with floors, counter tops, furniture or other finished surfaces will cause staining.
Poly-ureaurethane may cause stinging upon application. Instruct patients to discontinue use and consult a healthcare provider if redness/erythema or other signs of skin irritation occur.
Patients with isocyanate hypersensitivity should not use poly-ureaurethane.
Direct application to deep, open, or profusely bleeding wounds is contraindicated.
Information regarding the use of poly-ureaurethane during pregnancy is not provided by the manufacturer. However, because the solution is applied topically to the nail, clinically significant systemic absorption would not be expected.
Information regarding the use of poly-ureaurethane during breast-feeding is not provided by the manufacturer. However, because the solution is applied topically to the nail, clinically significant systemic absorption would not be expected. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For management of the signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails:
Topical dosage:
Adults: Apply once daily to entire affected nail plate, proximal and lateral folds, and the distal tip. Allow to dry completely before applying pads or clothing. Cleanse affected nails with nail polish remover once weekly.
Maximum Dosage Limits:
-Adults
1 application topically/day.
-Geriatric
1 application topically/day.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Poly-ureaurethane products.
Poly-ureaurethane is a biocompatible, polymeric solution that forms a waterproof barrier when applied to the nail. This barrier prevents direct abrasion and friction on the nail surface and protects against the effects of moisture.
Poly-ureaurethane is applied topically to the fingernail; clinically significant systemic absorption is not expected.