Luliconazole 10 mg/g Cream — NDC 68682-850-60 (Billing 68682-0850-60)
This is a package of Luliconazole 10 mg/g Cream from Oceanside Pharmaceuticals, marketed since Jun 2018 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 68682-850-60 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68682 labeler · 850 product · 60 package
- Package marketed since
- Jun 15, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0368682850604
- Medicaid fills, this package
- 41 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 071700
- GCN: 35638
- GPI-14 (Medi-Span): 90154048003720
- HICL (First Databank): 040763
- AHFS class code: 84:04.08.08
- RxCUI (RxNorm): 1482684
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Azole Antifungal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Luliconazole is used to treat tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body). Luliconazole is in a class of antifungal medications called azoles. It works by slowing the growth of fungi that cause infection.
Read the full MedlinePlus article ↗- Luzu (luliconazole) cream treats fungal skin infections. These are athlete’s foot between the toes, jock itch and ringworm of the body. It targets the fungi Trichophyton rubrum and...
- Apply a thin layer once a day to the affected skin and about an inch around it. Athlete’s foot is treated for 2 weeks. Jock itch and ringworm are treated for 1 week. Keep it out of...
- Side effects were uncommon. Skin reactions where you apply it happened in less than 1% of people, and most were mild. If irritation bothers you or doesn’t go away, check with me or...
- It may weakly affect CYP2C19, a liver enzyme that helps process some medicines. Tell me everything you take so I can check for any concerns.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Luliconazole — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $2.81 | $168.81 / 60 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q3 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68682-0850-60 You're viewing this Main listing | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | 2018-06-15 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Luliconazole 10 mg/gthis 68682-0850-60 | Oceanside | 1 tube | — | — | FDA listed | — |
| Luzu 10 mg/g 99207-0850-02 | Bausch | 12 tubes | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 9012484 ↗ | Drug substance | U-540 | Sep 6, 2033 |
| US 9453006 ↗ | Drug substance | — | Sep 6, 2033 |
| US 9199977 ↗ | Drug substance | — | Sep 6, 2033 |
| US 8980931 ↗ | Drug product | — | Apr 28, 2034 |
Is there a generic version of LULICONAZOLE 1% CREAM?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Luliconazole Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
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UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII CAL22UVI4M
A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Oceanside Pharmaceuticals labeler code 68682
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- Enalapril Maleate 5 mg Tablet NDC 68682-711-01
- Enalapril Maleate 10 mg Tablet NDC 68682-712-01
- Enalapril Maleate 20 mg Tablet NDC 68682-713-01
- Tretinoin .05 g/100g Gel NDC 68682-800-45
- Erythromycin and Benzoyl Peroxide Kit NDC 68682-900-23
- Erythromycin and Benzoyl Peroxide Kit NDC 68682-901-46
- Tetracaine Hydrochloride 5 mg/mL Solution/ Drops NDC 68682-920-05
- Tolcapone 100 mg Tablet, Film Coated NDC 68682-938-90
- Omeprazole and Sodium Bicarbonate 20 mg; 1680 mg Powder, For Suspension NDC 68682-990-30
- Diltiazem Hydrochloride 120 mg Capsule, Extended Release NDC 68682-993-98
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Luliconazole Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum . Luliconazole Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For topical use only. Luliconazole Cream, 1% is not for ophthalmic, oral, or intravaginal use. • When treating interdigital tinea pedis, a thin layer of Luliconazole Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 2 weeks. • When treating tinea cruris or tinea corporis, Luliconazole Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 1 week. • For topical use only.
Not for ophthalmic, oral, or intravaginal use. ( 2 ) • Interdigital Tinea Pedis: Luliconazole Cream, 1% should be applied to the affected and immediate surrounding area(s) once a day for 2 weeks. ( 2 ) • Tinea Cruris and Tinea Corporis: Luliconazole Cream, 1% should be applied to the affected skin and immediate surrounding area(s) once a day for 1 week.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Cream, 1%. Each gram of Luliconazole Cream, 1% contains 10 mg of luliconazole in a white cream base. Cream, 1% ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions observed in clinical trials were application site reactions, which occurred in less than 1% of subjects. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 three Phase 3 clinical trials, 616 subjects were exposed to Luliconazole Cream, 1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris. Subjects with interdigital tinea pedis or tinea cruris applied Luliconazole Cream, 1% or vehicle cream once daily for 14 days or 7 days, respectively, to affected and adjacent areas.
During clinical trials with Luliconazole Cream, 1%, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Luliconazole and vehicle arms. Most adverse reactions were mild in severity. A post-approval clinical trial was conducted in 75 subjects age 2 to <18 years old with tinea corporis.
The adverse reactions in the Luliconazole Cream, 1% treated population were similar to the vehicle treated population.
6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of luliconazole cream, 1%: contact dermatitis and cellulitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS An in vivo study in adult subjects with moderate to severe interdigital tinea pedis and tinea cruris showed that Luliconazole Cream, 1% is mostly a weak inhibitor of CYP2C19. In a separate trial in adolescent subjects with tinea cruris, in vivo blood levels of Luliconazole Cream, 1%, were seen to approach those levels sufficient to show moderate inhibition of CYP2C19 [see Clinical Pharmacology ( 12.3 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data with Luliconazole Cream, 1% use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies with pregnant rats and rabbits, there were no adverse developmental effects observed with subcutaneous administration of luliconazole during organogenesis at doses up to 3 and 24 times, respectively, the maximum recommended human dose (MRHD) [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data The animal multiples of human exposure calculations were based on daily dose body surface area (BSA) comparisons (mg/m 2 ) for the reproductive toxicology studies described in this section and in Section 13.1.
The maximum recommended human dose (MRHD) was set at 8 g 1% cream per day (1.33 mg/kg/day for a 60 kg individual, which is equivalent to 49.2 mg/m 2 /day). Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 7-17) to pregnant female rats.
No treatment-related effects on maternal toxicity or malformations were noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons). Increased incidences of skeletal variation (14 th rib) were noted at 25 mg/kg/day. No treatment-related effects on skeletal variation were noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons).
Subcutaneous doses of 4, 20 and 100 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 6-18) to pregnant female rabbits. No treatment-related effects on maternal toxicity, embryofetal toxicity or malformations were noted at 100 mg/kg/day (24 times the MRHD based on BSA comparisons). In a pre- and postnatal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered from the beginning of organogenesis (gestation day 7) 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 (0.6 times the MRHD based on BSA comparisons). No treatment effects on postnatal development were noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons).
8.2Lactation Risk Summary There is no information available on the presence of luliconazole in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production after topical application of Luliconazole Cream, 1% to women who are breastfeeding. Luliconazole Cream, 1% has low systemic absorption. The lack of clinical data during lactation precludes a clear determination of the risk of Luliconazole Cream, 1% to an infant during lactation.
Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Luliconazole Cream, 1% and any potential adverse effects on the breastfed infant from Luliconazole Cream, 1% or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of Luliconazole Cream, 1% in pediatric patients 12 to <18 years of age with tinea pedis and tinea cruris have been established by evidence from well-controlled trials in adult and pediatric subjects and a pharmacokinetic (PK) study in pediatric subjects [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] . The safety and effectiveness of Luliconazole Cream, 1% in pediatric patients 2 to <18 ye… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data with Luliconazole Cream, 1% use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies with pregnant rats and rabbits, there were no adverse developmental effects observed with subcutaneous administration of luliconazole during organogenesis at doses up to 3 and 24 times, respectively, the maximum recommended human dose (MRHD) [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data The animal multiples of human exposure calculations were based on daily dose body surface area (BSA) comparisons (mg/m 2 ) for the reproductive toxicology studies described in this section and in Section 13.1.
The maximum recommended human dose (MRHD) was set at 8 g 1% cream per day (1.33 mg/kg/day for a 60 kg individual, which is equivalent to 49.2 mg/m 2 /day). Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 7-17) to pregnant female rats.
No treatment-related effects on maternal toxicity or malformations were noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons). Increased incidences of skeletal variation (14 th rib) were noted at 25 mg/kg/day. No treatment-related effects on skeletal variation were noted at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons).
Subcutaneous doses of 4, 20 and 100 mg/kg/day luliconazole were administered during the period of organogenesis (gestational days 6-18) to pregnant female rabbits. No treatment-related effects on maternal toxicity, embryofetal toxicity or malformations were noted at 100 mg/kg/day (24 times the MRHD based on BSA comparisons). In a pre- and postnatal development study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered from the beginning of organogenesis (gestation day 7) 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 (0.6 times the MRHD based on BSA comparisons). No treatment effects on postnatal development were noted at 25 mg/kg/day (3 times the MRHD based on BSA comparisons).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Luliconazole Cream, 1% in pediatric patients 12 to <18 years of age with tinea pedis and tinea cruris have been established by evidence from well-controlled trials in adult and pediatric subjects and a pharmacokinetic (PK) study in pediatric subjects [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] . The safety and effectiveness of Luliconazole Cream, 1% in pediatric patients 2 to <18 years of age with tinea corporis have been established by evidence from a well-controlled trial in pediatric subjects [see Clinical Pharmacology (12.3) and Clinical Studies (14) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of subjects in clinical studies of Luliconazole Cream, 1%, 8% were 65 and over, while 1.4% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Luliconazole Cream, 1% is an azole antifungal [see Microbiology ( 12.4 )].
12.2Pharmacodynamics At therapeutic doses, Luliconazole Cream, 1% is not expected to prolong QTc to any clinically relevant extent.
12.3Pharmacokinetics Luliconazole is the R enantiomer of a chiral molecule. The potential for interconversion between R and S enantiomers in humans has not been assessed. Information on the pharmacokinetics of luliconazole presented below refers to both R enantiomer and S enantiomer, if any, combined.
Luliconazole is >99% protein bound in plasma. In a PK trial, 12 subjects with moderate to severe tinea pedis and 8 subjects with moderate to severe tinea cruris applied a mean daily amount of approximately 3.5 grams of Luliconazole Cream, 1% to the affected and surrounding areas once daily for 15 days. Plasma concentrations of luliconazole on Day 15 were measurable in all subjects and fluctuated little during the 24-hour interval.
In subjects with tinea pedis, the mean ± SD of the maximum concentration (C max ) was 0.40 ± 0.76 ng/mL after the first dose and 0.93 ± 1.23 ng/mL after the final dose. The mean time to reach C max (T max ) was 16.9 ± 9.39 hours after the first dose and 5.8 ± 7.61 hours after the final dose. Exposure to luliconazole, as expressed by area under the concentration time curve (AUC 0–24 ), was 6.88 ± 14.50 ng*hr/mL after the first dose and 18.74 ± 27.05 ng*hr/mL after the final dose.
In subjects with tinea cruris, the mean ± SD C max was 4.91 ± 2.51 ng/mL after the first dose and 7.36 ± 2.66 ng/mL after the final dose. The mean T max was 21.0 ± 5.55 hours after the first dose and 6.5 ± 8.25 hours after the final dose. Exposure to luliconazole, as expressed by AUC 0–24 , was 85.1 ± 43.69 ng*hr/mL after the first dose and 121.74 ± 53.36 ng*hr/mL after the final dose.
PK data of luliconazole measured in adolescent subjects (12 to <18 years of age) with moderate to severe interdigital tinea pedis or moderate to severe tinea cruris as well as in subjects 2 to <18 years of age with tinea corporis are described in Specific Populations below. Specific Populations PK of luliconazole was assessed in 30 adolescent subjects 12 to <18 years of age with moderate to severe interdigital tinea pedis (N=15) or moderate to severe tinea cruris (N=15). Subjects with tinea pedis applied approximately 3 grams of Luliconazole Cream, 1% once daily to the affected area and adjacent skin for 15 days, while subjects with tinea cruris applied Luliconazole Cream, 1% once daily to the affected and adjacent skin for 8 days.
Generally, the systemic exposure of luliconazole was greater in the subjects with tinea cruris than tinea pedis. In subjects with tinea pedis, the systemic concentrations of luliconazole were quantifiable in all the subjects on Day 8 and Day 15. The mean ± SD C max was 1.80 ± 1.86 ng/mL after the first dose on Day 1, and 3.93 ± 1.67 ng/mL and 3.27 ± 1.71 ng/mL on Days 8 and 15, respectively.
The mean ± SD AUC 0-24 was 20.47 ± 14.47 ng*hr/mL after the first dose on Day 1, and 64.94 ± 32.47 ng*hr/mL and 60.38 ± 37.92 ng*hr/mL on Days 8 and Day 15, respectively. Like in adult subjects, the mean plasma concentrations of luliconazole in adolescent subjects on Days 8 and 15 were similar and fluctuated little during a 24-hour interval. In subjects with moderate to severe tinea cruris, the systemic concentrations of luliconazole were quantifiable in all the subjects on Day 8.
The mean ± SD C max was 9.80 ± 5.94 ng/mL after the first dose (Day 1) and 15.40 ± 13.62 ng/mL after the last dose (Day 8). The mean ± SD AUC 0-24 was 157.07 ± 92.18 ng*hr/mL and 266.06 ± 236.07 ng*hr/mL, after the first dose (Day 1) and the last dose (Day 8). In subjects with tinea corporis, the systemic concentrations of luliconazole were assessed at pre-dose and at 6 hours post-dose on the last day of treatment following once daily treatment with Luliconazole Cream, 1% for 7 days.
The systemic conce… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Luliconazole Cream, 1% is an azole antifungal [see Microbiology ( 12.4 )].
Mechanism of Action Luliconazole is an antifungal that belongs to the azole class. Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Luliconazole Cream, 1% is a white cream supplied in tubes as follows: 60 g NDC 68682-850-60 Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Luliconazole Cream, 1% contains 1% luliconazole, an azole antifungal agent, in a white cream for topical application. Luliconazole is (2E)-2-[(4R)-4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene]-2-imidazol-1-ylacetonitrile. Its structural formula is: The molecular formula is C 14 H 9 Cl 2 N 3 S 2 with a molecular weight of 354.28.
Luliconazole is the R enantiomer and contains one chiral center. The double bond adjacent to the dithiolane group is in the E configuration. Luliconazole Cream, 1% contains 10 mg of luliconazole per gram of cream in a vehicle consisting of benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, isopropyl myristate, medium-chain triglycerides, methylparaben, polysorbate 60, propylene glycol, purified water, and sorbitan monostearate.
Luliconazole Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) . • Inform patients that Luliconazole Cream, 1% is for topical use only. Luliconazole Cream, 1% is not intended for intravaginal or ophthalmic use. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada U.S. Patent Numbers: 8,980,931; 9,012,484; 9,199,977 and 9,453,006 © 2020 Bausch Health Companies Inc. or its affiliates 9616403
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Luliconazole is the R enantiomer of a chiral molecule. The potential for interconversion between R and S enantiomers in humans has not been assessed. Information on the pharmacokinetics of luliconazole presented below refers to both R enantiomer and S enantiomer, if any, combined.
Luliconazole is >99% protein bound in plasma. In a PK trial, 12 subjects with moderate to severe tinea pedis and 8 subjects with moderate to severe tinea cruris applied a mean daily amount of approximately 3.5 grams of Luliconazole Cream, 1% to the affected and surrounding areas once daily for 15 days. Plasma concentrations of luliconazole on Day 15 were measurable in all subjects and fluctuated little during the 24-hour interval.
In subjects with tinea pedis, the mean ± SD of the maximum concentration (C max ) was 0.40 ± 0.76 ng/mL after the first dose and 0.93 ± 1.23 ng/mL after the final dose. The mean time to reach C max (T max ) was 16.9 ± 9.39 hours after the first dose and 5.8 ± 7.61 hours after the final dose. Exposure to luliconazole, as expressed by area under the concentration time curve (AUC 0–24 ), was 6.88 ± 14.50 ng*hr/mL after the first dose and 18.74 ± 27.05 ng*hr/mL after the final dose.
In subjects with tinea cruris, the mean ± SD C max was 4.91 ± 2.51 ng/mL after the first dose and 7.36 ± 2.66 ng/mL after the final dose. The mean T max was 21.0 ± 5.55 hours after the first dose and 6.5 ± 8.25 hours after the final dose. Exposure to luliconazole, as expressed by AUC 0–24 , was 85.1 ± 43.69 ng*hr/mL after the first dose and 121.74 ± 53.36 ng*hr/mL after the final dose.
PK data of luliconazole measured in adolescent subjects (12 to <18 years of age) with moderate to severe interdigital tinea pedis or moderate to severe tinea cruris as well as in subjects 2 to <18 years of age with tinea corporis are described in Specific Populations below. Specific Populations PK of luliconazole was assessed in 30 adolescent subjects 12 to <18 years of age with moderate to severe interdigital tinea pedis (N=15) or moderate to severe tinea cruris (N=15). Subjects with tinea pedis applied approximately 3 grams of Luliconazole Cream, 1% once daily to the affected area and adjacent skin for 15 days, while subjects with tinea cruris applied Luliconazole Cream, 1% once daily to the affected and adjacent skin for 8 days.
Generally, the systemic exposure of luliconazole was greater in the subjects with tinea cruris than tinea pedis. In subjects with tinea pedis, the systemic concentrations of luliconazole were quantifiable in all the subjects on Day 8 and Day 15. The mean ± SD C max was 1.80 ± 1.86 ng/mL after the first dose on Day 1, and 3.93 ± 1.67 ng/mL and 3.27 ± 1.71 ng/mL on Days 8 and 15, respectively.
The mean ± SD AUC 0-24 was 20.47 ± 14.47 ng*hr/mL after the first dose on Day 1, and 64.94 ± 32.47 ng*hr/mL and 60.38 ± 37.92 ng*hr/mL on Days 8 and Day 15, respectively. Like in adult subjects, the mean plasma concentrations of luliconazole in adolescent subjects on Days 8 and 15 were similar and fluctuated little during a 24-hour interval. In subjects with moderate to severe tinea cruris, the systemic concentrations of luliconazole were quantifiable in all the subjects on Day 8.
The mean ± SD C max was 9.80 ± 5.94 ng/mL after the first dose (Day 1) and 15.40 ± 13.62 ng/mL after the last dose (Day 8). The mean ± SD AUC 0-24 was 157.07 ± 92.18 ng*hr/mL and 266.06 ± 236.07 ng*hr/mL, after the first dose (Day 1) and the last dose (Day 8). In subjects with tinea corporis, the systemic concentrations of luliconazole were assessed at pre-dose and at 6 hours post-dose on the last day of treatment following once daily treatment with Luliconazole Cream, 1% for 7 days.
The systemic concentrations were quantifiable in all the 12 subjects and the mean ± SD daily dose of Luliconazole Cream, 1% was 2.84 ± 1.82 g. The mean ± SD concentrations of luliconazole at 15 minutes prior to dosing and at 6 hours post-dose on Day 7 were 4.63 ± 2.93 ng/mL a… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics At therapeutic doses, Luliconazole Cream, 1% is not expected to prolong QTc to any clinically relevant extent.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Interdigital Tinea Pedis The safety and efficacy of Luliconazole Cream, 1% was evaluated in two randomized, double-blind, vehicle-controlled, multi-center clinical trials in 423 subjects with a clinical and culture-confirmed diagnosis of interdigital tinea pedis. Subjects were randomized to receive Luliconazole Cream, 1% or vehicle. Subjects applied either Luliconazole Cream, 1% or vehicle cream to the entire area of the forefeet including all interdigital web spaces and approximately 2.5 cm (1 in) of the surrounding area of the foot once daily for 14 days.
The mean age of the study population was 41 years (range 13 to 78 years); 82% were male; 53% were White and 40% were Black or African American. Signs and symptoms of tinea pedis (erythema, scaling, and pruritus), KOH exam and dermatophyte culture were assessed at baseline, end-of-treatment (Day 14), 2 and 4 weeks post-treatment. Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 4 weeks post-treatment.
Luliconazole Cream, 1% demonstrated complete clearance in subjects with interdigital tinea pedis. Treatment outcomes at 4 weeks post-treatment are summarized in Table 1. Table 1: Efficacy Results at 4 Weeks Post-treatment – Interdigital Tinea Pedis Study 1 Study 2 Luliconazole Cream, 1% N=106 n (%) Vehicle Cream N=103 n (%) Luliconazole Cream, 1% N=107 n (%) Vehicle Cream N=107 n (%) Complete Clearance Proportion of subjects who achieved both clinical cure and mycological cure 28 (26%) 2 (2%) 15 (14%) 3 (3%) Effective Treatment Negative KOH and culture and at most mild erythema and/or scaling and no pruritus 51 (48%) 10 (10%) 35 (33%) 16 (15%) Clinical Cure Absence of erythema, scaling and pruritus 31 (29%) 8 (8%) 16 (15%) 4 (4%) Mycological Cure Negative KOH and negative fungal culture 66 (62%) 18 (18%) 60 (56%) 29 (27%)
14.2Tinea Cruris The safety and efficacy of Luliconazole Cream, 1% was evaluated in a randomized, double-blind, vehicle-controlled, multi-center clinical trial in 256 subjects with a clinical and culture-confirmed diagnosis of tinea cruris. Subjects were randomized to receive Luliconazole Cream, 1% or vehicle. Subjects applied either Luliconazole Cream, 1% or vehicle cream to the affected area and approximately 2.5 cm (1 in) of the surrounding area once daily for 7 days.
The mean age of the study population was 40 years (range 14 to 88 years); 83% were male; 58% were White and 34% were Black or African American. Signs and symptoms of tinea cruris (erythema, scaling, and pruritus), positive KOH exam and dermatophyte culture were assessed at baseline, end-of-treatment (Day 7), 2 and 3 weeks post-treatment. Overall treatment success was defined as complete clearance (clinical cure and mycological cure) at 3 weeks post-treatment.
Luliconazole Cream, 1% demonstrated complete clearance in subjects with tinea cruris. Treatment outcomes at 3 weeks post-treatment are summarized in Table 2. Table 2: Efficacy Results at 3 Weeks Post-treatment - Tinea Cruris Luliconazole Cream, 1% N=165 n (%) Vehicle Cream N=91 n (%) Complete Clearance Proportion of subjects who achieved both clinical cure and mycological cure 35 (21%) 4 (4%) Effective Treatment Negative KOH and culture and at most mild erythema and/or scaling and no pruritus 71 (43%) 17 (19%) Clinical Cure Absence of erythema, scaling and pruritus 40 (24%) 6 (7%) Mycological Cure Negative KOH and negative fungal culture 129 (78%) 41 (45%)
14.3Tinea Corporis The safety and efficacy of Luliconazole Cream, 1% was evaluated in a randomized, double-blind, vehicle-controlled, multi-center clinical trial in 75 subjects age 2 to <18 years old with a clinical and culture-confirmed diagnosis of tinea corporis. Subjects were randomized to receive Luliconazole Cream, 1% or vehicle cream. Subjects applied either Luliconazole Cream, 1% or vehicle cream to the affected area and approximately 2.5 cm (1 in) of the surrounding skin once daily for 7 days.
The mea… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of Luliconazole Cream, 1% have not been conducted. Luliconazole 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 chromosomal aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus test). In a fertility study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered prior to and during mating and through early pregnancy.
Treatment-related effects on reproductive function were noted in females (decreased live embryos and decreased corpus luteum) at 5 and 25 mg/kg/day and males (decreased sperm counts) at 25 mg/kg/day. No treatment-related effects on fertility or reproductive function were noted at 1 mg/kg/day (0.1× MRHD based on BSA comparisons).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of Luliconazole Cream, 1% have not been conducted. Luliconazole 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 chromosomal aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus test). In a fertility study in rats, subcutaneous doses of 1, 5 and 25 mg/kg/day luliconazole were administered prior to and during mating and through early pregnancy.
Treatment-related effects on reproductive function were noted in females (decreased live embryos and decreased corpus luteum) at 5 and 25 mg/kg/day and males (decreased sperm counts) at 25 mg/kg/day. No treatment-related effects on fertility or reproductive function were noted at 1 mg/kg/day (0.1× MRHD based on BSA comparisons).
📄 Patient Package Insert ▾
PATIENT INFORMATION Luliconazole Cream, 1% Important information: Luliconazole Cream is for use on skin only. Do not get Luliconazole Cream near or in your eyes, mouth or vagina. What is Luliconazole Cream?
Luliconazole Cream is a prescription medicine used on the skin (topical) to treat fungal infections in people with athlete's foot that is between the toes, jock itch, and ringworm. Before using Luliconazole Cream, tell your doctor about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. It is not known if Luliconazole Cream will harm your unborn baby. • are breastfeeding or plan to breastfeed.
It is not known if Luliconazole Cream passes into your breast milk. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use Luliconazole Cream? • Use Luliconazole Cream exactly as your doctor tells you to use it. • If you have athlete's foot between the toes, apply a thin layer of Luliconazole Cream to the affected skin areas and to about 1 inch of the surrounding skin 1 time a day for 2 weeks. • If you have jock itch or ringworm, apply Luliconazole Cream to the affected skin areas and to about 1 inch of the surrounding skin 1 time a day for 1 week. • Wash your hands after you apply Luliconazole Cream.
What are the possible side effects of Luliconazole Cream? Luliconazole Cream may cause skin reactions at the treatment site. Skin irritation may happen with Luliconazole Cream.
Tell your doctor if you have any skin reactions on the areas of your skin treated with Luliconazole Cream. These are not all the possible side effects of Luliconazole Cream. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. How should I store Luliconazole Cream? • Store Luliconazole Cream at room temperature between 68°F to 77°F (20°C to 25°C). Keep Luliconazole Cream and all medicines out of the reach of children.
General information about the safe and effective use of Luliconazole Cream Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Luliconazole Cream for a condition for which it was not prescribed. Do not give Luliconazole Cream to other people, even if they have the same symptoms that you have.
It may harm them. You can ask your pharmacist or doctor for information about Luliconazole Cream that is written for health professionals. What are the ingredients in Luliconazole Cream?
Active ingredient: luliconazole Inactive ingredients: benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, isopropyl myristate, medium-chain triglycerides, methylparaben, polysorbate 60, propylene glycol, purified water, sorbitan monostearate. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada U.S.
Patent Numbers: 8,980,931; 9,012,484; 9,199,977 and 9,453,006 © 2020 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: 04/2020 9616403
📄 Package Label / Principal Display Panel ▾
Click or tap here to enter text. NDC 68682-850-60 Rx only LULICONAZOLE CREAM 1% For Topical Use Only Not for ophthalmic, oral, or intravaginal use Keep Out of Reach of Children Net. Wt. 60 g OCEANSIDE PHARMACEUTICALS 60g carton 9616301
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