Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tavaborole topical solution, 5% is a clear colorless alcohol-based solution supplied in an amber colored glass bottle with a black screw cap. At initial use, the screw cap is replaced with the dropper assembly. Rubber dropper with glass pipette packed in BOPP pouch printed with "THIS DEVICE CONTAINS DRY NATURAL RUBBER". Tavaborole topical solution, 5% is supplied in the following presentations: NDC 69097-686-37: One bottle containing 10 mL of solution with one glass pointed-tip dropper. NDC 69097-686-34: One bottle containing 4 mL of solution with one glass pointed-tip dropper. 16.2 Storage and Handling Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame. Discard product within 3 months after insertion of the dropper. Keep bottle tightly closed. Keep out of reach of children.; 16.1 How Supplied Tavaborole topical solution, 5% is a clear colorless alcohol-based solution supplied in an amber colored glass bottle with a black screw cap. At initial use, the screw cap is replaced with the dropper assembly. Rubber dropper with glass pipette packed in BOPP pouch printed with "THIS DEVICE CONTAINS DRY NATURAL RUBBER". Tavaborole topical solution, 5% is supplied in the following presentations: NDC 69097-686-37: One bottle containing 10 mL of solution with one glass pointed-tip dropper. NDC 69097-686-34: One bottle containing 4 mL of solution with one glass pointed-tip dropper.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 69097-686-34 Rx Only Tavaborole Topical Solution 5 % For Topical Use Only Not for oral, ophthalmic, or intravaginal use 4 mL NDC 69097-686-34 Rx Only Tavaborole Topical Solution 5 % For Topical Use Only Not for oral, ophthalmic, or intravaginal use THIS PRODUCT DEVICE CONTAINS DRY NATURAL RUBBER 4 mL NDC 69097-686-37 Rx Only Tavaborole Topical Solution 5 % For Topical Use Only Not for oral, ophthalmic, or intravaginal use 10 mL NDC 69097-686-37 Rx Only Tavaborole Topical Solution 5 % For Topical Use Only Not for oral, ophthalmic, or intravaginal use THIS PRODUCT DEVICE CONTAINS DRY NATURAL RUBBER 10 mL 4ml 4ml 10ml 10ml
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tavaborole topical solution, 5% is a clear colorless alcohol-based solution supplied in an amber colored glass bottle with a black screw cap. At initial use, the screw cap is replaced with the dropper assembly. Rubber dropper with glass pipette packed in BOPP pouch printed with "THIS DEVICE CONTAINS DRY NATURAL RUBBER". Tavaborole topical solution, 5% is supplied in the following presentations: NDC 69097-686-37: One bottle containing 10 mL of solution with one glass pointed-tip dropper. NDC 69097-686-34: One bottle containing 4 mL of solution with one glass pointed-tip dropper. 16.2 Storage and Handling Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame. Discard product within 3 months after insertion of the dropper. Keep bottle tightly closed. Keep out of reach of children.
- 16.1 How Supplied Tavaborole topical solution, 5% is a clear colorless alcohol-based solution supplied in an amber colored glass bottle with a black screw cap. At initial use, the screw cap is replaced with the dropper assembly. Rubber dropper with glass pipette packed in BOPP pouch printed with "THIS DEVICE CONTAINS DRY NATURAL RUBBER". Tavaborole topical solution, 5% is supplied in the following presentations: NDC 69097-686-37: One bottle containing 10 mL of solution with one glass pointed-tip dropper. NDC 69097-686-34: One bottle containing 4 mL of solution with one glass pointed-tip dropper.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 69097-686-34 Rx Only Tavaborole Topical Solution 5 % For Topical Use Only Not for oral, ophthalmic, or intravaginal use 4 mL NDC 69097-686-34 Rx Only Tavaborole Topical Solution 5 % For Topical Use Only Not for oral, ophthalmic, or intravaginal use THIS PRODUCT DEVICE CONTAINS DRY NATURAL RUBBER 4 mL NDC 69097-686-37 Rx Only Tavaborole Topical Solution 5 % For Topical Use Only Not for oral, ophthalmic, or intravaginal use 10 mL NDC 69097-686-37 Rx Only Tavaborole Topical Solution 5 % For Topical Use Only Not for oral, ophthalmic, or intravaginal use THIS PRODUCT DEVICE CONTAINS DRY NATURAL RUBBER 10 mL 4ml 4ml 10ml 10ml
Overview
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 7 H 6 BFO 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 74.81 % (v/v), edetate calcium disodium, and propylene glycol. Image
Indications & Usage
Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes . Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes . ( 1 )
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. 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 )
Warnings & Precautions
No warnings available yet.
Contraindications
None. None. ( 4 )
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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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). Table 1: Adverse Reactions Occurring in ≥1% of Tavaborole Topical Solution, 5%-Treated Subjects and at a Greater Frequency than Observed with Vehicle Preferred Term Tavaborole Topical Solution N=791 n (%) Vehicle N=395 n (%) Application site exfoliation 21 (2.7%) 1 (0.3%) Ingrown toenail 20 (2.5%) 1 (0.3%) Application site erythema 13 (1.6%) 0 (0%) Application site dermatitis 10 (1.3%) 0 (0%) 6.2 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
Storage & Handling
16.2 Storage and Handling Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame. Discard product within 3 months after insertion of the dropper. Keep bottle tightly closed. Keep out of reach of children.
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