`
`
` CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`203567Orig1s000
`LABELING
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`
`
`• Not for oral, ophthalmic, or intravaginal use. (2)
`
` _____________ 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 Valeant
`Pharmaceuticals North America 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: 06/2014
`
`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.
`
`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, 10%
`For topical use
`Initial U.S. Approval: 2014
`
` __________________ INDICATIONS AND USAGE _________________
`JUBLIA is an azole antifungal indicated for the topical treatment of
`onychomycosis of the toenails 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. (2)
`
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`
`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
`8.3 Nursing Mothers
`8.4 Pediatric Use
`8.5 Geriatric Use
`11 DESCRIPTION
`
` 1
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`1
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`Reference ID: 3519795
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`1
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`
`FULL PRESCRIBING INFORMATION
`
`INDICATIONS AND USAGE
`1
`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.
`
`DOSAGE AND ADMINISTRATION
`2
`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.
`
`DOSAGE FORMS AND STRENGTHS
`3
`JUBLIA (efinaconazole) topical solution, 10% contains 100 mg of efinaconazole in each gram of
`clear, colorless to pale yellow solution.
`
`CONTRAINDICATIONS
`
`4
`None.
`
`6
`
`ADVERSE REACTIONS
`
`Clinical Trials Experience
`6.1
`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.
`
`Reference ID: 3519795
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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.
`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
`
`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
`
`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
`Pregnancy Category C
`There are no adequate and well-controlled studies with JUBLIA in pregnant women. JUBLIA
`should be used during pregnancy only if the potential benefit justifies the potential risk to the
`fetus.
`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 Maximum Recommended
`Human Dose (MRHD) based on Area Under the Curve (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).
`
`Reference ID: 3519795
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`3
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`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 post-natal 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).
`
`Nursing Mothers
`8.3
`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.
`
`Pediatric Use
`8.4
`Safety and effectiveness of JUBLIA in pediatric subjects have not been established.
`
`Geriatric Use
`8.5
`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.
`
`DESCRIPTION
`11
`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: 3519795
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`4
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`
`
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`
`
`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)].
`
`Pharmacodynamics
`12.2
`The pharmacodynamics of JUBLIA is unknown.
`
`Pharmacokinetics
`12.3
`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.
`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
`
`Reference ID: 3519795
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`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 μg/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
`
`Carcinogenesis, Mutagenesis, Impairment of Fertility
`13.1
`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).
`
`Reference ID: 3519795
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`No effects on fertility were observed in male and female rats that were administered
`subcutaneous doses up to 25 mg/kg/day efinaconzole (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).
`
`CLINICAL STUDIES
`14
`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, multi-center, randomized, double-blind
`clinical trials in patients 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.
`Table 2:
`Efficacy Endpoints
`
`
`
`Trial 1
`
`Trial 2
`
`Complete
`Curea
`
`Complete or
`Almost Complete
`Cureb
`Mycologic Curec
`
`JUBLIA
`
`N = 656
`
`117
`
`17.8%
`
`173
`
`26.4%
`
`362
`
`55.2%
`
`Vehicle
`
`N = 214
`
`7
`
`3.3%
`
`15
`
`7.0%
`
`36
`
`16.8%
`
`JUBLIA
`
`N = 580
`
`88
`
`15.2%
`
`136
`
`23.4%
`
`310
`
`53.4%
`
`Vehicle
`
`N = 201
`
`11
`
`5.5%
`
`15
`
`7.5%
`
`34
`
`16.9%
`
`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.
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`Reference ID: 3519795
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`7
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`HOW SUPPLIED/STORAGE AND HANDLING
`16
`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 - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP
`Controlled Room Temperature].
`
`• Solution is flammable; keep away from heat or flame
`
`• Protect from freezing
`
`• Keep out of the reach of children
`
`• Keep bottle tightly closed
`
`• Store in upright position
`
`PATIENT COUNSELING INFORMATION
`17
`See FDA-Approved Patient Labeling (Patient Information)
`
`• JUBLIA is for external use only and is not for ophthalmic, oral, 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 health care professional if the area of application shows signs of persistent
`irritation (for example, redness, itching, swelling).
`
`• Avoid pedicures, the use of nail polish, and cosmetic nail products while using JUBLIA.
`
`• Flammable, avoid use near heat or open flame.
`
`
`
`
`Reference ID: 3519795
`
`8
`
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`
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`Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
`Manufactured by: Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan
`Product of Japan
`
`U.S. Patents 8,039,494; 7,214,506
`9391900
`
`
`
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`Issued: 06/2014
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`Reference ID: 3519795
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`9
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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 in children.
`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” at the end of this Patient Information leaflet 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.
`
`
`What should I avoid while using JUBLIA?
`JUBLIA is flammable. Avoid heat and flame while applying JUBLIA to your toenail.
`•
`• Avoid pedicures, use of nail polish, or cosmetic nail products, while using JUBLIA.
`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 does 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°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.
`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 health 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.
`
`Reference ID: 3519795
`
`1
`
`
`
`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.
`
`Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807
`Manufactured by: Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan. Product of Japan
`For more information, call 1-800-321-4576.
`This Patient Information has been approved by the U.S. Food and Drug Administration.
`Issued: 06/2014
`
`
`
`
`Reference ID: 3519795
`
`2
`
`
`
`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 the 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.
`Step 1: Before you apply JUBLIA to your affected toenail, remove the cap from
`the JUBLIA bottle (See Figure A).
`
`
`Step 2: Hold the bottle directly over the affected toenail and gently squeeze the bottle to
`apply one drop of JUBLIA onto the toenail (See Figure B).
`
`
`Step 3: For the big toenail, also apply a second drop to the end of the toenail (See Figure
`C).
`
`
`
`1
`
`Reference ID: 3519795
`
`
`
`Step 4: Use the brush attached to the bottle to gently spread JUBLIA around the entire
`toenail including: the cuticle, folds of the skin next to the sides of the toenail, and
`underneath the nail (See Figure D). Do not squeeze the bottle while spreading
`JUBLIA with the brush.
`
`
`Step 5: Repeat Steps 2 to 4 to apply JUBLIA to each affected toenail.
`Step 6: Let JUBLIA dry completely.
`Step 7: After applying JUBLIA to your affected toenails, place the cap on the bottle and
`screw it on tightly.
`Step 8: Wash your hands with soap and water after applying JUBLIA.
`
`This Patient Information and Instructions for Use has been approved by the U.S. Food and
`Drug Administration.
`Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
`Manufactured by: Kaken Pharmaceutical Co. Ltd, Shizuoka, Japan.
`
`Product of Japan
`Issued: 06/2014
`
`
`Reference ID: 3519795
`
`2
`
`
`
`VALEANT
`'hll'llllcluflllll North Amerlce LLC
`
`VALEANT - US Pharmaceutical Labeling Group - 1400 North Goodman Street - Rochester, NY 14609 - USA
`GRAPHICS CONTACT:
`(b) (6)
`
`ARTWORK SET AT 1093?“)
`
`DESCRIPTION: 8 mL Jublia Topical Solution 10% Carton, US (PPS)
`PART No.: 9395500
`SPECIAL INSTRUCTIONS/ PLACED IMAGES: "/3
`
`DIELINE DOES NOT PRINT
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`Not for use in eyes
`
`8 mL
`
`
`
`
`
`
`
`
`
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`(efinaconazole)
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`Topical Solution, 10%
`
`For Topical Use Only
`Not for use in eyes
`
`8mL
`
`
`
`Reference ID: 3519795
`
`
`
`VALEANT
`Phormucouucal- North Amorle- LLC
`
`VALEANT - US Pharmaceutical Labeling Group - 1400 North Goodman Street - Rochester, NY 14609 - USA
`GRAPHICS CONTACT:
`(b) (6)
`
`ARTWORK SET AT 100543“)
`
`DESCRIPTION: 8 mL Jublia Topical Solution 10% Label, US (PPS)
`PART No.: 9395400
`SPECIAL INSTRUCTIONS] PLACED IMAGES: n/a
`
`DIELINE DOES NOT PRINT
`
`PROPR ETARY NOTICE: THIS DOCUMENTAND ALL NFORMATION HEREIN IS
`THE CONFIDENTIAL PROPERTY OF PHARMA PACKAG NG AND SHALL NOT
`BE COP ED, DISCLOSED TO THIRD PART ES CONFIDENTIALLY OR
`NON-CONFIDENTIALLY, PUBLICLY DISCLOSED, OR USED FOR ANY PURPOSE
`OTHER THAN THE SPECIFIC PURPOSE FOR WHICH IT WAS PROVIDED
`ITHOUT PRIOR WRITTEN AUTHORIZATION, AND SHALL BE DESTROYED OR
`RETURNED UPON DEMAND.
`
`
`
`
`APPROVALS
`DATE
`
`|<— 2.71875”—>| |<—.1562"
`
`
`
`RIM
`Ix at;
`“0137540008 Puma from freezing.
`III: 018764003! Platedfioni hazing.
`
`
`Flammableflup awayfmm
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`31111111111;be
`earring: by.
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`a
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`
`Bridgewater, III 08807USA
`Bridgewatu, II] 08807 USA
`
`
`
`
`6 2014
`Made in Japan
`@2014
`Madein
`"'1
`3 "'1
`9395400
`Issued 06/14
`9395400
`Issuedfl
`
`
`
`
`
`
`.031 2” or
`,0625”
`
`
`
`i
`90625”
`
`.
`
`
`
`JUBLIA.
`-‘
`'
`'
`(efinatonazole)
`TopKaI Solution, 10%
`For1»th Ila o",
`
`JUBLIA.
`'
`'
`'
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`Topical Solution, 10%
`FoyToplul u“ 0",
`
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`
`_
`
`I
`
`(01)00301375400033
`
`
`Notes
`1. Label material:
`"” ‘"
`2. Corner Radius:
`3‘ Space between iaoeis:
`4
`
`(”i“)
`
`“m"
`
`(b) (4)
`
`DATE: 05-08-14
`P.O.: Proof om
`JOB:
`(”""_
`MODtL HY:
`COLORS-
`
`
`M (4)
`
`Pharma Packaging
`LABEL: Die Line
`DRAWING/ITEM NUMBER
`Die Line .90625 x 2.71875
`SHEET 1 OF 1 —
`— Die line is for reference only
`
`
`
`SIZE
`.90625" x 2.71875"
`SCALE 1:1
`
`
`
`(0) (4)
`
`
`
`
`Rmtfiivmggipglfiggcummt is unoonflolled unless printed with the
`next word 'Controlled' in red and issued by the ISO Quality Systems Manager.
`
`FORM ART 5 R1 6-06-13
`
`
`
`VALEANT
`Phlrmucnuclcfll North Amorlcl LLC
`
`VALEANT - US Pharmaceutical Labeling Group - 1400 North Goodman Street - Rochester, NY 14609 - USA
`GRAPHICS CONTACT:
`(m6)
`
`ARTWORK SET AT 100%“)
`
`DESCRIPTION: 4 mL Jublia Topical Solution 10% Carton, US (PPS)
`PART No.: 9391100
`SPECIAL INSTRUCTIONS] PLACED IMAGES: n/a
`
`DIELINE DOES NOT PRINT
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`Reference ID: 3519795
`
`
`
`VALEANT
`Pharmaceutical: North Amorleo LLC
`
`VALEANT - US Pharmaceutical Labeling Group - 1400 North Goodman Street - Rochester, NY 14609 - USA
`GRAPHICS CONTACT:
`(b) (6)
`
`ARTWORK SET AT 100$“)
`
`DESCRIPTION: 4 mL Jublia Topical Solution 10% Label, US (PPS)
`PART No.: 9391200
`SPECIAL INSTRUCTIONS] PLACED IMAGES: n/a
`
`DIELINE DOES NOT PRINT
`
`PROPR ETARY NOTICE: THIS DOCUMENTAND ALL NFORMATION HEREIN IS
`THE CONFIDENTIAL PROPERTY OF PHARMA PACKAG NG AND SHALL NOT
`BE COP ED, DISCLOSED TO THIRD PART ES CONFIDENTIALLY OR
`NON-CONFIDENTIALLY, PUBLICLY DISCLOSED, OR USED FOR ANY PURPOSE
`OTHER THAN THE SPECIFIC PURPOSE FOR WHICH TT WAS PROVIDED
`ITHOUT PRIOR WRITTEN AUTHORIZATION, AND SHALL BE DESTROYED OR
`RETURNED UPON DEMAND.
`
`
`
`
`APPROVALS
`DATE
`
`|<— 2.71875”—>| |<—.1562"
`
`
`
`RIM
`Ix on;
`“0137540004 Puma from freezing.
`III: 0187640004 Platedfioni hazing.
`
`
`Flammable; Imp mayhem
`Flammableflup awayfmm
`
`
`_
`heateiflame.
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`Bridgewater, III 08807USA
`Bridgewatu, II] 08807 USA
`6 2014
`Made in Japan
`©2014
`Madein
`9391200
`Issued 06/14
`9391100
`Issued
`
`i
`90625”
`
`.
`
`
`
`
`JUBLIA.
`-'
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`
`
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`
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`
`.031 2” or
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`
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`(01“11301875m
`
`_
`
`
`
`
`
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`
`(111)00301375400040H{my
`
`
`Notes
`1. Label material:
`"” ‘"
`2. Corner Radius:
`3‘ Space between iaoeis:
`4
`
`(”i“)
`
`“m"
`
`(b) (4)
`
`DATE: 05-08-14
`P.O.: Proof om
`JOB:
`(”""_
`MODtL BY:
`COLORS-
`
`
`M (4)
`
`Pharma Packaging
`LABEL: Die Line
`DRAWING/ITEM NUMBER
`Die Line .90625 x 2.71875
`SHEET 1 OF 1 —
`— Die line is for reference only
`
`
`
`SIZE
`.90625" x 2.71875"
`SCALE 1:1
`
`
`
`
`
`
`M14)
`
`Rmtfévmggrpglpiggcummt is uncontrolled unless printed with the
`next word 'Controlled' in red and issued by the ISO Quality Systems Manager.
`
`FORM ART 5 R1 6-06-13
`
`
`
`VALEANT
`Phlrmucnuclcnls North Amer-In LLC
`
`VALEANT - US Pharmaceutical Labeling Group - 1400 North Goodman Street - Rochester, NY 14609 - USA
`GRAPHICS CONTACT:
`(m6)
`
`ARTWORK SET AT 100%)“,
`
`DESCRIPTION: 4 mL Jublia Topical Solution 10% Sample Carton, US (PPS)
`PART No.: 9390900
`SPECIAL INSTRUCTIONS] PLACED IMAGES: n/a
`
`DIELINE DOES NOT PRINT
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`I mum"
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`I|I|Illll|llll|1
`
`
`
`
`Reference ID: 3519795
`
`
`
`VALEANT
`Pharmaceutical: North Amorleo LLC
`
`VALEANT - US Pharmaceutical Labeling Group - 1400 North Goodman Street - Rochester, NY 14609 - USA
`GRAPHICS CONTACT:
`(b) (6)
`
`(MW
`
`DESCRIPTION: 4 mL Jublia Topical Solution 10% Sample Label, US (PPS)
`PART No.: 9391000
`SPECIAL INSTRUCTIONS] PLACED IMAGES: n/a
`
`DIELINE DOES NOT PRINT
`
`ARTWORK SET AT 100%
`
`PROPR ETARY NOTICE: THIS DOCUMENTAND ALL NFORMATION HEREIN IS
`THE CONFIDENTIAL PROPERTY OF PHARMA PACKAG NG AND SHALL NOT
`BE COP ED, DISCLOSED TO THIRD PART ES CONFIDENTIALLY OR
`NON-CONFIDENTIALLY, PUBLICLY DISCLOSED, OR USED FOR ANY PURPOSE
`OTHER THAN THE SPECIFIC PURPOSE FOR WHICH TT WAS PROVIDED
`ITHOUT PRIOR WRITTEN AUTHORIZATION, AND SHALL BE DESTROYED OR
`RETURNED UPON DEMAND.
`
`
`
`
`APPROVALS
`DATE
`
`
`
`.
`
`90625”
`
`
`
`|<— 2.71875”—>| |<—.1562"
`
`
`
`RIM
`
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`Topical Solution, 10%
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`Issud 06/14
`93910“)
`Issued% I
`
`
`
`
`
`
`.031 2” or
`,0625”
`
`
`
`(O1)nosoumom01
`
`(01)mm1375mn101
`
`
`Notes
`1. Label material:
`"M
`2. Corner Radius:
`3. Space between labels: M“)
`4
`
`“m"
`
`(b) (4)
`
`DATE: 05-08-14
`P.O.: Proof om
`JOB:
`(”""_
`MODtL HY:
`COLORS.
`
`
`(W)
`
`Pharma Packaging
`LABEL: Die Line
`DRAWING/ITEM NUMBER
`Die Line .90625 x 2.71875
`SHEET 1 OF 1 —
`— Die line is for reference only
`
`
`
`SIZE
`.90625" x 2.71875"
`SCALE 1 :1
`
`
`
`
`
`
`(13) I)
`
`Rmtfévmggrpglpiggcummt is unoonflolled unless printed with the
`next word 'Controlled' in red and issued by the ISO Quality Systems Manager.
`
`FORW ART 5 R1 6-06-13
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JULIE G BEITZ
`06/06/2014
`
`Reference ID: 3519795
`
`