PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

NDC 51862-690-10

Tavaborole
Topical
Solution, 5%

For Topical Use Only

Not for oral, ophthalmic,
or intravaginal use

Rx Only

10 mL

mayne pharma

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DESCRIPTION SECTION

11 DESCRIPTION

Tavaborole topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal with the chemical name of 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole. The chemical formula is C 7H 6BFO 2, the molecular weight is 151.93 and the structural formula is:

Tavaborole is a white to off-white powder. It is slightly soluble in water and freely soluble in ethanol and propylene glycol.

Each mL of tavaborole topical solution contains 43.5 mg of tavaborole. Inactive ingredients include alcohol USP (87.43% v/v), propylene glycol USP, and edetate calcium disodium USP

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INDICATIONS & USAGE SECTION

1 INDICATIONS & USAGE

Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrumor Trichophyton mentagrophytes.

DOSAGE & ADMINISTRATION SECTION

2 DOSAGE & 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.

DOSAGE FORMS & STRENGTHS SECTION

3 DOSAGE FORMS & STRENGTHS

Tavaborole topical solution, 5% is a clear, colorless alcohol-based solution. Each milliliter of solution contains 43.5 mg (5% w/w) of tavaborole

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CONTRAINDICATIONS SECTION

Highlight: None. ( 4)

4 CONTRAINDICATIONS

None.

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CLINICAL STUDIES SECTION

14 CLINICAL STUDIES

The efficacy and safety of tavaborole topical solution was evaluated in two multicenter, double-blind, randomized, vehicle-controlled trials. Tavaborole topical solution or vehicle was applied once daily for 48 weeks in subjects with 20% to 60% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement.

A total of 1194 subjects (795 tavaborole topical solution, 399 Vehicle) 18 to 88 years of age, 82% male, 84% white, participated in these two trials. Efficacy assessments were made at 52 weeks following a 48-week treatment period.

The Complete Cure efficacy endpoint included negative mycology (negative KOH wet mount and negative fungal culture) and Completely Clear Nail (no clinical evidence of onychomycosis as evidenced by a normal toenail plate, no onycholysis, and no subungual hyperkeratosis). Efficacy results from the two trials are summarized in Table 2.

Table 2: Efficacy Outcomes

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INFORMATION FOR PATIENTS SECTION

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling ( Patient Informationand Instructions for Use)

The patient should be told the following:

• The impact of nail polish or other cosmetic nail products on the efficacy of tavaborole topical solution has not been evaluated.
• Inform a health care professional if the area of application shows sign of persistent irritation (for example, redness, itching, swelling).
• Product is flammable. Avoid use near heat or open flame.

SPL PATIENT PACKAGE INSERT SECTION

PATIENT INFORMATION

Tavaborole (ta va bor ole) topical solution, 5%

**Important information: Tavaborole topical solution is for use on toenails only.**Do not use tavaborole topical solution in your mouth, eyes, or vagina.

What is tavaborole topical solution?

Tavaborole topical solution is a prescription medicine used to treat fungal infections of the toenails.

It is not known if tavaborole topical solution is safe and effective in children less than 6 years age.

Before using tavaborole topical solution, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if tavaborole topical solution can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if tavaborole passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during your treatment with tavaborole topical solution.

**Tell your healthcare provider about all the medicines you take,**including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use tavaborole topical solution?

See the "Instructions for Use" at the end of this Patient Information for detailed information about the right way to use tavaborole topical solution.

• Use tavaborole topical solution exactly as your healthcare provider tells you to use it.
• Apply tavaborole topical solution to your affected toenails 1 time each day.
• Tavaborole topical solution is used for 48 weeks.
• It is not known if the use of nail polish or other cosmetic nail products (such as gel nails or acrylic nails) will affect how tavaborole topical solution works.

What should I avoid while using tavaborole topical solution?

• Tavaborole topical solution is flammable. Avoid heat and flame while applying tavaborole topical solution to your toenail.

What are the possible side effects of tavaborole topical solution?

The most common side effects of tavaborole topical solution include: skin peeling, ingrown toenail, redness, itching, and swelling.

Tavaborole topical solution may cause irritation at or near the application site. Tell your healthcare provider if you develop irritation at the application site that does not go away. These are not all of the possible side effects of tavaborole topical solution.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store tavaborole topical solution?

• Store tavaborole topical solution at room temperature, between 68°F to 77°F (20°C to 25°C).
• Tavaborole topical solution is flammable. Keep away from heat and flame.
• Keep the bottle tightly closed.
• Safely throw away tavaborole topical solution after 3 months of inserting the dropper.

Keep tavaborole topical solution and all medicines out of the reach of children.

General information about the safe and effective use of tavaborole topical solution

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tavaborole topical solution for a condition for which it was not prescribed. Do not give tavaborole topical solution to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about tavaborole topical solution that is written for health professionals.

What are the ingredients in tavaborole topical solution?

**Active ingredient:**tavaborole

**Inactive ingredients:**alcohol USP (87.43% v/v), propylene glycol USP, and edetate calcium disodium USP

Distributed by:
Mayne Pharma
Raleigh, NC 27609

Revised: 10/2022

For more information, call Encube Ethicals Private Limited at 1-866-495-2621or FDA at1-800-FDA-1088

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised 10/2022

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SPL UNCLASSIFIED SECTION

Code: GO/DRUGS/361

MTS5/01

Distributed by:
Mayne Pharma
Raleigh, NC 27609

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