Itraconazole 1% | Terbinafine HCl 3% | Tea Tree Oil 6.6% | Urea 10% | Biotin 0.6% | DMSO 10%

Route: Topical. Apply to thoroughly cleaned, dried affected nail(s) and surrounding hyponychium once or twice daily. File the nail surface gently with an emery board before application to maximize penetration. DMSO-containing formulations may produce a garlic-like odor and sensation upon application — this is expected. Avoid contact with mucous membranes and eyes. Wash hands after application. Do not apply to broken or severely inflamed skin.

Dosing is prescriber-determined:

• Typically once or twice daily application to affected nails.
• Nail debridement by the clinician may be combined with topical therapy for improved efficacy.
• Duration of treatment corresponds to nail growth: months for fingernails, up to 12+ months for toenails.
• Prescriber will define duration based on clinical response, culture, and tolerability.

• Itraconazole 1%: Inhibits CYP51/lanosterol 14α-demethylase in the ergosterol biosynthesis pathway, disrupting fungal membrane permeability.
• Terbinafine HCl 3%: Inhibits fungal squalene epoxidase (fungicidal against dermatophytes via squalene accumulation) at a higher concentration than standard monotherapy for improved nail plate penetration.
• Tea Tree Oil 6.6%: Terpinen-4-ol disrupts fungal membrane permeability, inhibits fungal respiration and ATPase, and inhibits biofilm formation; anti-inflammatory via TNF-α/IL-1β suppression.
• Urea 10%: Breaks intramolecular hydrogen bonds in nail keratin, softening the nail plate and enhancing penetration (diffusion coefficients) of co-applied antifungal agents into the nail.
• Biotin 0.6%: Coenzyme for carboxylase enzymes involved in fatty acid synthesis and amino acid metabolism in keratinocytes; supports nail keratin structure and quality.
• DMSO 10%: Small amphipathic molecule that partitions into the lipid-rich intercellular spaces of the nail plate, transiently altering the protein-lipid microstructure and reducing diffusion barriers to significantly enhance transungual flux of co-formulated antifungals.

This comprehensive multi-component formulation is reserved for prescriber-directed treatment of moderate-to-severe or treatment-refractory onychomycosis, particularly when single-agent topical therapy is insufficient and systemic antifungal therapy is contraindicated or patient-declined. The combination of dual ergosterol-blocking antifungals, membrane-disrupting TTO, nail-softening urea, and DMSO penetration enhancement provides a synergistic, multi-mechanism approach to transungual antifungal delivery.

Monitoring: Nail culture and/or KOH at baseline; reassess clinical response at 12–16 weeks; monitor for contact sensitization (especially TTO at 6.6%); check for DMSO-related adverse effects (garlic taste/odor, mild warmth).

Contraindications:

• Known hypersensitivity to itraconazole, terbinafine, tea tree oil, urea, biotin, DMSO, or formulation components.
• Avoid in pregnancy (DMSO safety in pregnancy is not established).

Warnings & Precautions:

• DMSO: causes garlic-like taste/odor (metabolite dimethylsulfide); may carry systemic substances through skin — do not apply to skin in contact with other topical agents intended to remain localized.
• Tea tree oil 6.6%: higher sensitization risk than lower concentrations; patch test consideration in atopic patients.
• Urea 10%: avoid on broken skin; may cause mild burning on inflamed skin.

Drug Interactions:

• DMSO may enhance systemic absorption of any co-applied agents; use as directed and apply only to nail surface.

Common Side Effects: Garlic odor/taste (DMSO), mild local burning or stinging, contact dermatitis (TTO), nail bed irritation.

Store at room temperature (15°C–25°C). Keep tightly sealed; DMSO and tea tree oil are volatile. Protect from light and heat. Do not freeze. Use within the beyond-use date assigned by Genesis Compounding.

Why does this medication have a garlic odor?

DMSO (dimethyl sulfoxide), the penetration enhancer in this formula, is metabolized to dimethylsulfide, which produces a characteristic garlic-like taste and body odor. This is an expected, harmless side effect that typically resolves between applications.

What does urea do in this nail formula?

Urea (10%) is a keratolytic agent that softens the nail plate by disrupting hydrogen bonds in nail keratin. This makes the nail more permeable to the antifungal ingredients, significantly enhancing their penetration into the nail matrix where the fungal infection resides.

Why are two antifungals used together?

Itraconazole and terbinafine target different enzymes in the ergosterol biosynthesis pathway (CYP51 vs. squalene epoxidase), providing synergistic antifungal coverage. This dual-mechanism approach is particularly beneficial for resistant infections or mixed fungal species.

Is this FDA-approved?

No. This is a patient-specific, prescriber-directed 503A compounded preparation from Genesis Compounding, not FDA-approved as a compounded drug.

How long will treatment take?

Onychomycosis treatment duration is linked to nail growth rate: typically 6 months for fingernails and 9–12 months for toenails. Consistent daily application and nail debridement by the clinician improve outcomes. Your prescriber will monitor progress and define the treatment course.