Mediclarum
Medicine guide

Jublia

100 mg/mL · Solution

  • Prescription only
  • Azole Antifungal
Active substance
Efinaconazole
Made by
Bausch Health US LLC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-07-01

What it is

Azole Antifungal

Used for
  • JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes .
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes .
  • JUBLIA is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes .
  • (1)

From the official label · 2025-07-01 · DailyMed

How it works

From this product’s own US prescribing label.

JUBLIA topical solution is an azole antifungal [ see Clinical Pharmacology (12.4) ].

Half-life7 days
Mostly cleared after≈ 5 weeksfive half-lives — our arithmetic

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-07-01

Do not take it if

None. None. (4)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator. When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered. JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.
  • Apply JUBLIA to affected toenails once daily for 48 weeks using the integrated flow-through brush applicator. (2)
  • When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered. (2)
  • For topical use only. Not for oral, ophthalmic, or intravaginal use. (2)

Quoted from the official label, section “Dosage & Administration”.

Pregnancy and breastfeeding

  • Risk Summary There are no available human data for the use of JUBLIA during pregnancy to inform any drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • In animal reproduction studies, efinaconazole did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at subcutaneous doses up to 112 and 154 times, respectively, the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons.
  • Embryolethality was observed only in rats in the presence of maternal toxicity at systemic exposures 559 times the MRHD based on AUC comparisons.
  • Subcutaneous efinaconazole administration to pregnant rats from the beginning of organogenesis through the end of lactation did not cause embryofetal toxicity or developmental effects at systemic exposures 17 times the MRHD based on AUC comparisons (see Data) .
  • The background risk of major birth defects and miscarriage for the indicated population is unknown.
  • However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.
  • Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits.
  • Subcutaneous doses of 2, 10 and 50 mg/kg/day efinaconazole were administered during the period of organogenesis (gestational days 6-16) to pregnant female rats.
  • In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal deaths, decreased number of live fetuses, and placental effects) was noted at 50 mg/kg/day (559 times the MRHD based on AUC comparisons).
  • No embryofetal toxicity was noted at 10 mg/kg/day (112 times the MRHD based on AUC comparisons).
  • No malformations were observed at 50 mg/kg/day (559 times the MRHD based on AUC comparisons).
  • Subcutaneous doses of 1, 5, and 10 mg/kg/day efinaconazole were administered during the period of organogenesis (gestational days 6-19) to pregnant female rabbits.
  • In the presence of maternal toxicity, there was no embryofetal toxicity or malformations at 10 mg/kg/day (154 times the MRHD based on AUC comparisons).
  • In a pre- and postnatal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day efinaconazole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20).
  • In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25 mg/kg/day.
  • No embryofetal toxicity was noted at 5 mg/kg/day (17 times the MRHD based on AUC comparisons).
  • No effects on postnatal development were noted at 25 mg/kg/day (89 times the MRHD based on AUC comparisons).
  • IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy Risk Summary There are no available human data for the use of JUBLIA during pregnancy to inform any drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • In animal reproduction studies, efinaconazole did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at subcutaneous doses up to 112 and 154 times, respectively, the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons.
  • Embryolethality was observed only in rats in the presence of maternal toxicity at systemic exposures 559 times the MRHD based on AUC comparisons.
  • Subcutaneous efinaconazole administration to pregnant rats from the beginning of organogenesis through the end of lactation did not cause embryofetal toxicity or developmental effects at systemic exposures 17 times the MRHD based on AUC comparisons (see Data) .
  • The background risk of major birth defects and miscarriage for the indicated population is unknown.
  • However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.
  • Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits.
  • Subcutaneous doses of 2, 10 and 50 mg/kg/day efinaconazole were administered during the period of organogenesis (gestational days 6-16) to pregnant female rats.
  • In the presence of maternal toxicity, embryofetal toxicity (increased embryofetal deaths, decreased number of live fetuses, and placental effects) was noted at 50 mg/kg/day (559 times the MRHD based on AUC comparisons).
  • No embryofetal toxicity was noted at 10 mg/kg/day (112 times the MRHD based on AUC comparisons).
  • No malformations were observed at 50 mg/kg/day (559 times the MRHD based on AUC comparisons).
  • Subcutaneous doses of 1, 5, and 10 mg/kg/day efinaconazole were administered during the period of organogenesis (gestational days 6-19) to pregnant female rabbits.
  • In the presence of maternal toxicity, there was no embryofetal toxicity or malformations at 10 mg/kg/day (154 times the MRHD based on AUC comparisons).
  • In a pre- and postnatal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day efinaconazole were administered from the beginning of organogenesis (gestation day 6) through the end of lactation (lactation day 20).
  • In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup mortality, reduced live litter sizes and increased postnatal pup mortality) was noted at 25 mg/kg/day.
  • No embryofetal toxicity was noted at 5 mg/kg/day (17 times the MRHD based on AUC comparisons).
  • No effects on postnatal development were noted at 25 mg/kg/day (89 times the MRHD based on AUC comparisons).
  • 8.2 Lactation Risk Summary It is not known whether efinaconazole is excreted in human milk.
  • After repeated subcutaneous administration, efinaconazole was detected in milk of nursing rats.
  • Because many drugs are excreted in human milk, caution should be exercised when JUBLIA is administered to nursing women.
  • The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for JUBLIA, and any potential adverse effects on the breastfed infant from JUBLIA.
  • 8.4 Pediatric Use The safety and effectiveness of JUBLIA were established in patients 6 years and older.
  • Use of JUBLIA in these age groups is supported by evidence from well-controlled trials in
  • adults with additional data from an open-label safety study in 60 pediatric subjects ages 6 to 17 (including a pharmacokinetic study in 17 subjects 12 years to less than 17 years old) [see Clinical Pharmacology (12.3) ].
  • Safety and effectiveness of JUBLIA in pediatric subjects under 6 years of age have not been established.
  • 8.5 Geriatric Use Of the total number of subjects in clinical trials of JUBLIA, 11.3% were 65 and over, while none were 75 and over.
  • No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and the younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

Quoted from the official label, section “Drug Interactions”.

Use in children

  • The safety and effectiveness of JUBLIA were established in patients 6 years and older.
  • Use of JUBLIA in these age groups is supported by evidence from well-controlled trials in
  • adults with additional data from an open-label safety study in 60 pediatric subjects ages 6 to 17 (including a pharmacokinetic study in 17 subjects 12 years to less than 17 years old) [see Clinical Pharmacology (12.3) ].
  • Safety and effectiveness of JUBLIA in pediatric subjects under 6 years of age have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Of the total number of subjects in clinical trials of JUBLIA, 11.3% were 65 and over, while none were 75 and over.
  • No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and the younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The most common adverse reactions (incidence >1%) were ingrown toenails, application site dermatitis, application site vesicles, and application site pain.
  • (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 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, 1227 subjects were treated with JUBLIA, 1161 for at least 24 weeks and 780 for 48 weeks.
  • Adverse reactions reported within 48 weeks of treatment and in at least 1% of subjects treated with JUBLIA and those reported in subjects treated with the vehicle are presented in Table 1 .
  • Table 1:
  • Adverse Reactions Reported by at Least 1% of Subjects Treated for up to 48 Weeks Adverse Event, n (%) JUBLIA (N=1,227) Vehicle (N=413) Ingrown toenail 28 (2.3%) 3 (0.7%) Application site dermatitis 27 (2.2%) 1 (0.2%) Application site vesicles 20 (1.6%) 0 (0.0%) Application site pain 13 (1.1%) 1 (0.2%)
  • 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of JUBLIA.
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
  • General Disorders and Administration Site Conditions:
  • Application site erythema and exfoliation Skin and Subcutaneous Tissue Disorders:
  • Onychomadesis, Nail discoloration

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • JUBLIA is for external use only and is not for oral, ophthalmic, or intravaginal use. It is for use on toenails and immediately adjacent skin only.
  • Apply JUBLIA once daily to clean dry toenails. Wait for at least 10 minutes after showering, bathing, or washing before applying.
  • Use JUBLIA only on the affected toenails, as directed by your healthcare provider.
  • Inform a healthcare professional if the area of application shows signs of persistent irritation (for example, redness, itching, swelling).
  • The impact of nail polish or other cosmetic nail products on the efficacy of JUBLIA has not been evaluated.
  • Flammable, avoid use near heat or open flame.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS JUBLIA (efinaconazole) topical solution, 10% contains 100 mg of efinaconazole in each gram of clear, colorless to pale yellow solution. Solution:
  • 10%. (3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution supplied in a white plastic bottle with an integrated flow-through brush applicator as follows:
  • 4 mL (NDC 0187-5400-04)
  • 8 mL (NDC 0187-5400-08) Storage and Handling Conditions:
  • Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
  • Solution is flammable; keep away from heat or flame.
  • Protect from freezing.
  • Keep out of reach of children.
  • Keep bottle tightly closed.
  • Store in upright position.

Quoted from the official label, section “How Supplied”.

How to store it

  • Conditions:
  • Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
  • Solution is flammable; keep away from heat or flame.
  • Protect from freezing.
  • Keep out of reach of children.
  • Keep bottle tightly closed.
  • Store in upright position.

Quoted from the official label, section “Storage and Handling”.

What is in it

  • JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution for topical use.
  • Each gram of JUBLIA contains 100 mg of efinaconazole.
  • Efinaconazole is an azole antifungal with a chemical name of ((2R,3R)-2-(2,4-difluorophenyl)-3-(4-methylenepiperidin-1-yl)-1-(1H-1,2,4-triazol-1-yl) butan-2-ol).
  • The structural formula for efinaconazole is represented below:
  • JUBLIA contains the following inactive ingredients:
  • alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water. chemical structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Alcohol (ethanol)alcoholMatters for children, in pregnancy, in recovery and with some medicines.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (1)

Details

Made byBausch Health US LLC
Active substanceEfinaconazole
Used inAntibiotics, antivirals and antifungals taken into the body
Strength100 mg/mL
FormSolution
RouteTopical
Packs1 BOTTLE, WITH APPLICATOR in 1 CARTON / 2 mL in 1 BOTTLE, WITH APPLICATOR · 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 4 mL in 1 BOTTLE, WITH APPLICATOR
NDC0187-5400

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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