`
` HIGHLIGHTS OF PRESCRIBING INFORMATION
`
`
`
`
`
`
`These highlights do not include all the information needed to use
`
`
`
`
`JUBLIA safely and effectively. See full prescribing information for
`
`JUBLIA.
`
`JUBLIA® (efinaconazole) topical solution
`
`
`
`
`
`
`Initial U.S. Approval: 2014
`
`
`
`
`
`--------------------------- INDICATIONS AND USAGE -------------------------­
`
`JUBLIA is an azole antifungal indicated for the topical treatment of
`
`
`
`onychomycosis of the toenail(s) due to Trichophyton rubrum and
`
`Trichophyton mentagrophytes. (1)
`
`---------------------- DOSAGE AND ADMINISTRATION ---------------------­
`
`
`
`
`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)
`
`
`
`
`
`•
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`
`1 INDICATIONS AND USAGE
`
`2 DOSAGE AND ADMINISTRATION
`
`3 DOSAGE FORMS AND STRENGTHS
`
`4 CONTRAINDICATIONS
`
`6 ADVERSE REACTIONS
`
`6.1 Clinical Trials Experience
`
`
`7 DRUG INTERACTIONS
`
`8 USE IN SPECIFIC POPULATIONS
`
`8.1 Pregnancy
`
`8.2 Lactation
`
`
`8.4 Pediatric Use
`
`8.5 Geriatric Use
`
`11 DESCRIPTION
`
`
`
` FULL PRESCRIBING INFORMATION
`
`
`
` 1 INDICATIONS AND USAGE
`
`--------------------- DOSAGE FORMS AND STRENGTHS -------------------­
`
`
`
`
`Solution: 10%. (3)
`
`
`
`------------------------------ CONTRAINDICATIONS ----------------------------­
`
`
`
`
`None. (4)
`
`
`
`------------------------------ ADVERSE REACTIONS ----------------------------­
`
`
`
`
`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.
`
`
`See 17 for PATIENT COUNSELING INFORMATION and FDA-
`
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`
`
`
`approved patient labeling.
`
`
`Revised: 04/2020
`
`
`
`
`12 CLINICAL PHARMACOLOGY
`
`12.1 Mechanism of Action
`
`12.2 Pharmacodynamics
`
`12.3 Pharmacokinetics
`
`12.4 Microbiology
`
`13 NONCLINICAL TOXICOLOGY
`
`
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`
`
`
`14 CLINICAL STUDIES
`
`
`16 HOW SUPPLIED/STORAGE AND HANDLING
`
`
`17 PATIENT COUNSELING INFORMATION
`
`
`
`*Sections or subsections omitted from the full prescribing information are not listed.
`
`
`
`
`
`
`
` 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.
`
`
`
`
`
`
`
`
`
`
`
`
`
` 2 DOSAGE AND ADMINISTRATION
`
`
`
`
`
`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.
`
`
`
`
`
` 3 DOSAGE FORMS AND STRENGTHS
`
`
`
`
` JUBLIA (efinaconazole) topical solution, 10% contains 100 mg of efinaconazole in each gram of clear, colorless to pale
`
` yellow solution.
`
`
`
` 4 CONTRAINDICATIONS
`
`
`
`
`
` None.
`
`Reference ID: 4596291
`
`

`

`
`
` 6 ADVERSE REACTIONS
`
`
`
` 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.
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`
`
`
` 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.
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`
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` Table 1: Adverse Reactions Reported by at Least 1% of Subjects Treated for up to 48 Weeks
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` Adverse Event, n (%)
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`
`
` Ingrown toenail
`
` Application site dermatitis
` Application site vesicles
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`
`
` Application site pain
`
`
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`
`
`JUBLIA
`
`
` N = 1227
`
` 28 (2.3%)
`
` 27 (2.2%)
`
` 20 (1.6%)
`
` 13 (1.1%)
`
`Vehicle
`
`
` N = 413
`
` 3 (0.7%)
`
` 1 (0.2%)
`
` 0 (0.0%)
`
` 1 (0.2%)
`
`
`
` 7 DRUG INTERACTIONS
`
`
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` In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor induces cytochrome P450
`
`
` (CYP450) enzymes.
`
`
`
`
`
`
`
` 8 USE 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
`
`
`
`
`
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`birth defects, miscarriage, or adverse maternal or fetal outcomes.
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`
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`In animal reproduction studies, efinaconazole did not cause malformations or any harm to the fetus when administered to
`
`
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`pregnant rabbits and rats during the period of organogenesis at subcutaneous doses up to 112 and 154 times, respectively,
`
`
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`
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`the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons.
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`Embryolethality was observed only in rats in the presence of maternal toxicity at systemic exposures 559 times the
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`MRHD based on AUC comparisons. Subcutaneous efinaconazole administration to pregnant rats from the beginning of
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`organogenesis through the end of lactation did not cause embryofetal toxicity or developmental effects at systemic
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`exposures 17 times the MRHD based on AUC comparisons (see Data).
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`The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the
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`background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of
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`clinically recognized pregnancies.
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`Data
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`Animal Data
`
`Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 2, 10 and
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`50 mg/kg/day efinaconazole were administered during the period of organogenesis (gestational days 6-16) to pregnant
`
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`Reference ID: 4596291
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`

`

`
` 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
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`
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` embryofetal toxicity was noted at 10 mg/kg/day (112 times the MRHD based on AUC comparisons). No malformations
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`
` were observed at 50 mg/kg/day (559 times the MRHD based on AUC comparisons).
`
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`
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` Subcutaneous doses of 1, 5, and 10 mg/kg/day efinaconazole were administered during the period of organogenesis
`
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` (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).
`
`
`
`
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`
`
` 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
`
`
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`
` (89 times the MRHD based on AUC comparisons).
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` 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.
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`
`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.
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`
`
` 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
`
`
`
`
`
` pharmacokinetic study of JUBLIA in subjects 12 years to less than 17 years old [see Clinical Pharmacology (12.3)].
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`
`
` Safety and effectiveness of JUBLIA in pediatric subjects under 6 years of age have not been established.
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` 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.
`
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`
`
`
`
`
`
` 11 DESCRIPTION
`
`
`
`
`
`
`
`
` 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:
`
`
`
`Reference ID: 4596291
`
`

`

`Molecular Formula: C18H22F2N4O
`
`
`Molecular Weight: 348.39
`
`
`
`JUBLIA contains the following inactive ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15
`
`alkyl lactate, cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.
`
`
`
`
`
`
` 12 CLINICAL PHARMACOLOGY
`
`
`
` 12.1 Mechanism of Action
`
`
`
`
` JUBLIA topical solution is an azole antifungal [see Clinical Pharmacology (12.4)].
`
`
`
`
`
`
`
`
` 12.2 Pharmacodynamics
`
`
`
` The pharmacodynamics of JUBLIA is unknown.
`
`
`
` 12.3 Pharmacokinetics
`
`
` Systemic absorption of efinaconazole in 18 adult subjects with severe onychomycosis was determined after application of
`
`
`
`
` JUBLIA once daily for 28 days to patients’ 10 toenails and 0.5 cm adjacent skin. The concentration of efinaconazole in
` plasma was determined at multiple time points over the course of 24-hour periods on days 1, 14, and 28. Efinaconazole
`
`
`mean ± SD plasma Cmax on Day 28 was 0.67 ± 0.37 ng/mL and the mean ± SD AUC was 12.15 ± 6.91 ng*h/mL. The
`
`
`plasma concentration versus time profile at steady state was generally flat over a 24-hour dosing interval. In a separate
`
`
`study of healthy volunteers, the plasma half-life of efinaconazole following daily applications when applied to all
`
`
`10 toenails for 7 days was 29.9 hours.
`
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`
`Specific Populations
`
`
`Pediatric patients
`
`
`PK of efinaconazole was assessed in 17 pediatric subjects 12 to <17 years of age with moderate to severe onychomycosis
`
`
`
`following application of JUBLIA once daily to all 10 toenails for 28 days.
`
`
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`
`
`The plasma concentrations of efinaconazole in pediatric subjects were relatively flat over a 24-hour dosing interval. The
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`
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`mean ± SD plasma Cmax and AUC0-24 for efinaconazole on Day 28 were 0.55±0.38 ng/mL and 11.4±7.68 h•ng/mL,
`
`
`
`
`
`
`
`respectively.
`
`
`
`Drug Interactions
`
`
`Reference ID: 4596291
`
`

`

`
`
`JUBLIA is considered a non-inhibitor of the CYP450 enzyme family. In in vitro studies using human liver microsomes,
`
`efinaconazole did not inhibit CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2PE1 and CYP3A4
`
`
`
`
`
`enzyme activities at expected clinical systemic concentrations. In vitro studies in human primary hepatocytes showed that
`
`
`efinaconazole did not induce CYP1A2 or CYP3A4 activities.
`
` 12.4 Microbiology
`
`
`
`Mechanism of Action
`
`
`
`
`
` Efinaconazole is an azole antifungal. Efinaconazole inhibits fungal lanosterol 14α-demethylase involved in the
`
` biosynthesis of ergosterol, a constituent of fungal cell membranes.
`
`
`
`
` Activity In Vitro and In Vivo
`
`
`
`
`
`
`
` Efinaconazole has been shown to be active against isolates of the following microorganisms, both in vitro and in clinical
` infections. Efinaconazole exhibits in vitro minimum inhibitory concentrations (MICs) of 0.06 mcg/mL or less against
`
`
`
`
` most (≥90%) isolates of the following microorganisms:
`
`
`
` Trichophyton rubrum
`
` Trichophyton mentagrophytes
`
`
`
`Mechanism of Resistance
`
` Efinaconazole drug resistance development was studied in vitro against T. mentagrophytes, T. rubrum and C. albicans.
`
`
`
`
`
`Serial passage of fungal cultures in the presence of sub-growth inhibitory concentrations of efinaconazole increased the
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`
`
`
`
`MIC by up to 4-fold. The clinical significance of these in vitro results is unknown.
`
`
`
` 13 NONCLINICAL TOXICOLOGY
`
`
`
` 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`
`
` A 2-year dermal carcinogenicity study in mice was conducted with daily topical administration of 3%, 10% and 30%
`
`
`
`
`
` efinaconazole solution. Severe irritation was noted at the treatment site in all dose groups, which was attributed to the
`
`
`
` vehicle and confounded the interpretation of skin effects by efinaconazole. The high dose group was terminated at week
`
`
`
` 34 due to severe skin reactions. No drug-related neoplasms were noted at doses up to 10% efinaconazole solution
`
` (248 times the MRHD based on AUC comparisons).
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`
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`
` Efinaconazole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity
`
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`
`
` tests (Ames assay and Chinese hamster lung cell chromosome aberration assay) and one in vivo genotoxicity test (mouse
`
` peripheral reticulocyte micronucleus assay).
`
`
`
` No effects on fertility were observed in male and female rats that were administered subcutaneous doses up to
`
`
`
`
`
`
` 25 mg/kg/day efinaconazole (279 times the MRHD based on AUC comparisons) prior to and during early pregnancy.
` Efinaconazole delayed the estrous cycle in females at 25 mg/kg/day but not at 5 mg/kg/day (56 times MRHD based on
`
`
`
`
`
`
` AUC comparisons).
`
`
`
` 14 CLINICAL STUDIES
`
`
`
` The safety and efficacy of once daily use of JUBLIA for the treatment of onychomycosis of the toenail were assessed in
`
`
`
`
`
`
` two 52-week prospective, multicenter, randomized, double-blind clinical trials in subjects 18 years and older (18 to
` 70 years of age) with 20% to 50% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix)
`
`
`
`
`
` involvement. The trials compared 48 weeks of treatment with JUBLIA to the vehicle solution. The Complete Cure rate
`
`
`
`
` was assessed at Week 52 (4 weeks after completion of therapy). Complete cure was defined as 0% involvement of the
`
`
`
`
`
`
` target toenail (no clinical evidence of onychomycosis of the target toenail) in addition to Mycologic Cure, defined as both
`
`
`
`
`negative fungal culture and negative KOH. Table 2 lists the efficacy results for trials 1 and 2.
`
`
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`
` Table 2: Efficacy Endpoints
`
`
`
`Reference ID: 4596291
`
`

`

`
`
`
`
` Trial 1
`
`
`
` Trial 2
`
`
` JUBLIA
`
` N = 656
`
` 117
`
` 17.8%
`
` 173
` 26.4%
`
`
`Vehicle
`
`
` N = 214
`
` 7
`
` 3.3%
`
` 15
` 7.0%
`
`
`JUBLIA
`
`
` N = 580
`
` 88
`
` 15.2%
`
` 136
` 23.4%
`
`
`Vehicle
`
`
` N = 201
`
` 11
`
` 5.5%
`
` 15
` 7.5%
`
`
`
` Complete
`
` Curea
`
` Complete
`
` or Almost
`
` Complete
`
`
` Cureb
`
` Mycologic
` 34
` 310
` 36
` 362
`
`
`
`
`
` Curec
`
`
`
`
` 55.2%
` 16.8%
` 16.9%
` 53.4%
`
`
`
` a Complete cure defined as 0% clinical involvement of the target toenail plus negative KOH and negative culture.
`
`
`
`
`
`
`
`
`
`b Complete or almost complete cure defined as ≤5% affected target toenail area involved and negative KOH and culture.
`
`
`c Mycologic cure defined as negative KOH and negative culture.
`
`
`
`
` 16 HOW SUPPLIED/STORAGE AND HANDLING
`
`
`
`
`
` 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° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° 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.
`
`
`
`
`
`
`
`
`
`
`
` 17 PATIENT COUNSELING INFORMATION
`
`
`
`
`
`
`
`
`
`
`
` 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.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Distributed by:
`
` Bausch Health US, LLC
`
` Bridgewater, NJ 08807 USA
`
`
`
`
`
` Manufactured by:
`
`
`
`Reference ID: 4596291
`
`

`

`
`Kaken Pharmaceutical Co., Ltd.
`
`Shizuoka-ken 426-8646, Japan
`
`
`Or
`
`
`
`Bausch Health Companies Inc.
`
`Laval, Quebec H7L 4A8, Canada
`
`
`
`
`U.S. Patent Numbers 7,214,506; 8,039,494; 8,486,978; and 9,302,009
`
`
`
`
`
`
`JUBLIA is a trademark of Bausch Health Companies Inc. or its affiliates.
`
`
`
`
`© 2020 Bausch Health Companies Inc. or its affiliates
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`
`
`Update p/n
`
`Reference ID: 4596291
`
`

`

`PATIENT INFORMATION
`
`
` JUBLIA® (joo-blee-uh)
`
` (efinaconazole) topical solution, 10%
`
`
` Important information: JUBLIA is for use on toenails and surrounding skin only. Do not use JUBLIA in your
`
`
`
`
`
`
` mouth, eyes, or vagina.
`What is JUBLIA?
`
`
`JUBLIA is a prescription medicine used to treat fungal infections of the toenails.
`
`
`
`
`
`It is not known if JUBLIA is safe and effective for use in children under 6 years of age.
`What should I tell my healthcare provider before using JUBLIA?
`
`
`
`
`
`
`
`Before you use JUBLIA, tell your healthcare provider about all your medical conditions, including if you:
`
`
`
`
`• are pregnant or plan to become pregnant. It is not known if JUBLIA can harm your unborn baby.
`
`
`
`• are breastfeeding or plan to breastfeed. It is not known if JUBLIA passes into your breast milk.
`
`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 JUBLIA?
`
`
`See the “Instructions for Use” for detailed information about the right way to use JUBLIA.
`
`
`• Use JUBLIA exactly as your healthcare provider tells you to use it.
`
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`• Apply JUBLIA to your affected toenails 1 time each day. Wait for at least 10 minutes after showering, bathing, or
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`washing before applying JUBLIA.
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`JUBLIA is used for 48 weeks.
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`It is not known if the use of nail polish or other cosmetic nail products (such as gel nails or acrylic nails) will
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`affect how JUBLIA works.
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`What should I avoid while using JUBLIA?
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`JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
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`What are the possible side effects of JUBLIA?
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`JUBLIA may cause irritation at the treated site. The most common side effects include: ingrown toenail, redness,
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`itching, swelling, burning or stinging, blisters, and pain. Tell your healthcare provider if you have any side effects that
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`bother you or that do not go away.
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`These are not all the possible side effects of JUBLIA.
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`Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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`How should I store JUBLIA?
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`• Store JUBLIA at room temperature, between 68° to 77°F (20° to 25°C). Do not freeze JUBLIA.
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`• Keep the bottle tightly closed and store in an upright position.
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`JUBLIA is flammable. Keep away from heat and flame.
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`Keep JUBLIA and all medicines out of reach of children.
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`General information about the safe and effective use of JUBLIA
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`Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can
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`ask your pharmacist or healthcare provider for information about JUBLIA that is written for healthcare professionals.
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`Do not use JUBLIA for a condition for which it was not prescribed. Do not give JUBLIA to other people, even if they
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`have the same condition you have. It may harm them.
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`What are the ingredients in JUBLIA?
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`Active ingredients: efinaconazole
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`Inactive ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate,
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`cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.
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` Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA
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` Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada
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` U.S. Patent Numbers 7,214,506; 8,039,494; 8,486,978; and 9,302,009
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` JUBLIA is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates
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`For more information, call 1-800-321-4576.
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`This Patient Information has been approved by the U.S. Food and Drug Administration.
`Revised: 04/2020
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`Reference ID: 4596291
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