`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
`6.2 Postmarketing Experience
`7 DRUG INTERACTIONS
`8 USE IN SPECIFIC POPULATIONS
`8.1 Pregnancy
`8.2 Lactation
`8.4 Pediatric Use
`8.5 Geriatric Use
`
`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-
`approved patient labeling.
`
`Revised: 03/2022
`
`
`
`11 DESCRIPTION
`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: 4957127
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`
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`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.
`
`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 (%)
`
`Ingrown toenail
`Application site dermatitis
`Application site vesicles
`Application site pain
`
`6.2 Postmarketing Experience
`
`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%)
`
`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
`
`
` 7
`
` DRUG INTERACTIONS
`
`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
`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).
`
`Reference ID: 4957127
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`
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`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.
`
`Reference ID: 4957127
`
`
`
`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:
`
`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.
`
`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.
`
`Reference ID: 4957127
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`
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`The plasma concentrations of efinaconazole in pediatric subjects were relatively flat over a 24-hour dosing interval. The
`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
`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
`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).
`
`Efinaconazole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity
`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
`
`Reference ID: 4957127
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`
`
`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.
`
`Table 2: Efficacy Endpoints
`
`
`
`Trial 1
`
`Trial 2
`
`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%
`
`JUBLIA
`N = 656
`117
`17.8%
`173
`26.4%
`
`Complete
`Curea
`Complete
`or Almost
`Complete
`Cureb
`Mycologic
`34
`310
`36
`362
`Curec
`16.9%
`53.4%
`16.8%
`55.2%
`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°C to 25°C (68°F 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.
`
`Reference ID: 4957127
`
`
`
`Distributed by:
`Bausch Health US, LLC
`Bridgewater, NJ 08807 USA
`
`Manufactured by:
`Bausch Health Companies Inc.
`Laval, Quebec H7L 4A8, Canada
`
`U.S. Patent Numbers 7,214,506; 8,039,494; 8,486,978; 9,302,009; 9,566,272; 9,662,394; 9,861,698; 9,877,955;
`10,105,444; 10,342,875, 10,478,601; 10,512,640; 10,828,293; 10,828,369 and 10,864,274
`
`JUBLIA is a trademark of Bausch Health Companies Inc. or its affiliates.
`© 2022 Bausch Health Companies Inc. or its affiliates
`
`
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`Reference ID: 4957127
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`
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`•
`•
`
`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.
`• Apply JUBLIA to your affected toenails 1 time each day. Wait for at least 10 minutes after
`showering, bathing, or washing before applying JUBLIA.
`JUBLIA 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 JUBLIA works.
`What should I avoid while using JUBLIA?
`JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
`•
`What are the possible side effects of JUBLIA?
`JUBLIA may cause irritation at the treated site. The most common side effects include: ingrown
`toenail, redness, itching, swelling, burning or stinging, blisters, and pain. Tell your healthcare provider
`if you have any side effects that bother you or that do not go away.
`These are not all the possible side effects of JUBLIA.
`Call your doctor for medical advice about side effects. You may report side effects to the FDA at
`1-800-FDA-1088.
`How should I store JUBLIA?
`• Store JUBLIA at room temperature, between 68° to 77°F (20° to 25°C). Do not freeze JUBLIA.
`• Keep the bottle tightly closed and store in an upright position.
`JUBLIA is flammable. Keep away from heat and flame.
`•
`Keep JUBLIA and all medicines out of reach of children.
`General information about the safe and effective use of JUBLIA
`Medicines are sometimes prescribed for purposes other than those listed in a Patient Information
`leaflet. You can ask your pharmacist or healthcare provider for information about JUBLIA that is
`written for healthcare professionals. Do not use JUBLIA for a condition for which it was not
`prescribed. Do not give JUBLIA to other people, even if they have the same condition you have. It
`may harm them.
`What are the ingredients in JUBLIA?
`Active ingredients: efinaconazole
`Inactive ingredients: alcohol, anhydrous citric acid, butylated hydroxytoluene, C12-15 alkyl lactate,
`cyclomethicone, diisopropyl adipate, disodium edetate, and purified water.
`Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA
`
`Reference ID: 4957127
`
`
`
`Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada
`U.S. Patent Numbers 7,214,506; 8,039,494; 8,486,978; 9,302,009; 9,566,272; 9,662,394; 9,861,698;
`9,877,955; 10,105,444; 10,342,875; 10,478,601; 10,512,640; 10,828,293; 10,828,369 and 10,864,274
`JUBLIA is a trademark of Bausch Health Companies Inc. or its affiliates.
`© 2022 Bausch Health Companies Inc. or its affiliates
`For more information, call 1-800-321-4576.
`This Patient Information has been approved by the U.S. Food and Drug Administration.
`
`Revised: 03/2022
`
`
`Reference ID: 4957127
`
`
`
`INSTRUCTIONS FOR USE
`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.
`Read this Instructions for Use that comes with JUBLIA before you start using it. Talk to your healthcare provider if you
`have any questions.
`How to apply JUBLIA:
`Your toenails should be clean and dry before you apply JUBLIA. Wait at least 10 minutes after showering,
`bathing, or washing before applying JUBLIA.
`Step 1: Remove the cap from the JUBLIA bottle.
`
`
`
`
`
`
`
`Step 2.Prepare JUBLIA for application.
`
`• Hold the JUBLIA bottle upside down directly over the
`affected toenail and gently squeeze the bottle to moisten the
`entire brush with the solution.
`
`
`
`Step 3. Apply JUBLIA
`
`• While holding the bottle upside down, use the moistened
`brush to apply JUBLIA by brushing it gently onto the
`affected toenail(s). Gently squeeze the JUBLIA bottle to
`moisten the brush if needed.
`• Gently spread JUBLIA over the entire toenail around the
`cuticle, folds of the skin next to the sides of the toenail, and
`underneath the end of the toenail.
`• Do not squeeze bottle while spreading JUBLIA.
`Do not press or rub the brush firmly against the toenail.
`
`
`Step 4: For the big toenail, repeat Step 3 to apply JUBLIA a second
`time.
`
`
`
`
`Step 5: After applying JUBLIA, the entire toenail and surrounding skin should be covered with the solution. Let the
`treated area dry completely before covering it with bedding, socks, or other clothing.
`Step 6: Replace the cap tightly on the bottle.
`Step 7: Wash your hands with soap and water after applying JUBLIA.
`
`Reference ID: 4957127
`
`
`
`
`How should I store JUBLIA?
`• Store JUBLIA at room temperature, between 68°F to 77°F (20°C to 25°C). Do not freeze JUBLIA.
`• Keep the bottle tightly closed and store in an upright position.
`JUBLIA is flammable. Keep away from heat and flame.
`•
`Keep JUBLIA and all medicines out of the reach of children.
`Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA
`Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada
`U.S. Patent Numbers: 7,214,506; 8,039,494; 8,486,978; 9,302,009; 9,566,272; 9,662,394; 9,861,698; 9,877,955; 10,105,444; 10,342,875; 10,478,601; 10,512,640;
`10,828,293; 10,828,369 and 10,864,274
`JUBLIA is a trademark of Bausch Health Companies Inc. or its affiliates.
`© 2022 Bausch Health Companies Inc. or its affiliates
`
`
`
`This Instructions for Use has been approved by the Food and Drug Administration.
`
`
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`
`
`
`
`
`
`Revised 03/2022
`
`Reference ID: 4957127
`
`