CLOTIC (clotrimazole) otic solution 1.7 mg/.17mL Liquid — NDC 15370-220-28 (Billing 15370-0220-28)
This is a package of CLOTIC (clotrimazole) otic solution 1.7 mg/.17mL Liquid from Carwin Pharmaceutical Associates, LLC, marketed since Feb 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 15370-220-28 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 15370 labeler · 220 product · 28 package
- Package marketed since
- Feb 19, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 1537022028 7
- FDA record last changed
- Jul 24, 2026
Other active recalls for Clotrimazole (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 2725165
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
- It treats fungal and yeast infections. Skin products treat athlete's foot, jock itch and ringworm. Vaginal creams treat vaginal yeast infections, and CLOTIC ear solution treats fun...
- Wash and dry the area, then apply a thin layer twice a day, morning and night. Most labels say about 4 weeks for athlete's foot and ringworm and 2 weeks for jock itch. See a doctor...
- The skin products listed here say they are not effective on the scalp or nails. If the infection is there, check with your doctor.
- With CLOTIC ear solution, the reported ones were headache, pain where it goes in, ringing in the ear and tingling. Vaginal cream can briefly increase burning or itching. Call your...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clotrimazole — 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| 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 · refreshed Oct 5, 2026
- 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 |
|---|---|---|---|---|
| 15370-0220-28 You're viewing this Main listing | 2 POUCH in 1 CARTON / 14 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE | 2026-02-19 | — | Active |
| 15370-0220-99 15370-220-99 | 1 POUCH in 1 CARTON / 2 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE Sample | 2026-02-19 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of CLOTIC (clotrimazole) otic solution 1.7 mg/.17mL Liquid?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| CLOTIC (clotrimazole) otic solution 1.7 mg/.17mLthis 15370-0220-28 | Carwin | 2 pouches | — | — | 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 12246006 ↗ | Method of use | U-4276 | May 26, 2042 |
| Code | What it grants | Expires |
|---|---|---|
| NP | New Product | Sep 26, 2028 |
| ODE-549 | Orphan Drug Exclusivity (7-year) | Sep 26, 2032 |
| GAIN | Qualified Infectious Disease Product (+5-year) | Sep 26, 2037 |
| GAIN | Qualified Infectious Disease Product (+5-year) | Sep 26, 2033 |
Is there a generic version of this drug?
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
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 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 Clotrimazole 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- 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 Carwin Pharmaceutical Associates, LLC labeler code 15370
- Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE 1200 [iU]/1; 60 mg; 400 [iU]/1; 15 [iU]/1; 1.2 mg; 1.3 mg; 5 mg; 1.5 mg; 108 ug Tablet, Chewable NDC 15370-105-30
- RyVent carbinoxamine maleate 6 mg Tablet NDC 15370-130-02
- RYCLORA Dexchlorpheniramine Maleate 2 mg/5mL Liquid NDC 15370-150-04
- Relafen DS Nabumetone 1000 mg Tablet NDC 15370-170-10
- Lofena Diclofenac Potassium 25 mg Tablet, Film Coated NDC 15370-180-10
- Diclofenac Potassium 25 mg Tablet, Film Coated NDC 15370-185-30
- TriStart DHA ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, an 55 mg; 1000 [iU]/1; 15 [iU]/1; 1.3 mg; 1.8 mg; 5 mg; 35 mg; 600 ug; 400 ug Capsule, Liquid Filled NDC 15370-250-30
- POKONZA Potassium Chloride .75 g/.79g Powder, For Solution NDC 15370-305-04
- Pokonza potassium chloride 1.125 g/1.185g Powder, For Solution NDC 15370-306-30
- POKONZA potassium chloride 10 meq/15mL Liquid NDC 15370-307-04
- Opipza Aripiprazole 2 mg Film, Soluble NDC 15370-401-30
- Opipza Aripiprazole 5 mg Film, Soluble NDC 15370-402-30
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 CLOTIC is indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. Limitations of Use CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes.
CLOTIC is an azole antifungal indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. ( 1 ) Limitations of Use CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION CLOTIC is for otic use only. ( 2 ) Instill the contents of one single-dose CLOTIC vial into the affected ear canal twice daily, morning and evening, preferably 12 hours apart for 14 consecutive days. ( 2 ) See full prescribing information for preparation and administration instructions
2.1Recommended Dosage and Administration CLOTIC is for otic use only. Instill the contents of one single-dose CLOTIC vial into the affected ear canal twice daily morning and evening, preferably 12 hours apart, for 14 consecutive days.
2.2Preparation and Administration Instructions Warm the solution by holding the vial in the hand for 1 to 2 minutes. This is to avoid dizziness which may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward, and then instill the medication.
Gently pull the outer ear lobe upward and outward. This will allow the ear drops to flow down into the ear canal. Maintain this position for 1 minute after the drug administration.
Repeat, if necessary, for the opposite ear [see Instructions for Use ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Otic solution: Each single-dose vial of CLOTIC (clotrimazole) otic solution, 1%, delivers approximately 0.17 mL of solution equivalent to 1.7 mg of clotrimazole. The solution is clear colorless to slightly yellow. Otic solution: Each single-dose vial of CLOTIC (clotrimazole) otic solution, 1%, delivers approximately 0.17 mL of solution equivalent to 1.7 mg of clotrimazole. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS CLOTIC is contraindicated in patients with known hypersensitivity to clotrimazole. CLOTIC is contraindicated in patients with known hypersensitivity to clotrimazole. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS None. None. ( 5 )
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions that occurred in ≥ 1 patient were headache, application site pain, tinnitus, tympanic membrane perforation, and paresthesia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Carwin Pharmaceutical Associates, LLC at phone 1-844-700-5011 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 two randomized, placebo-controlled, phase 3 trials, 393 adult patients with otomycosis and intact tympanic membranes were treated with CLOTIC or placebo (Trial 1 and Trial 2) twice daily for a median duration of 14 days. There were 261 patients who received at least one dose of CLOTIC and 132 patients received at least one dose of placebo.
These patients had a mean age of 51 years (range 19 to 89 years); 55% were male, 87% were White, and 26% were Hispanic or Latino ethnicity. Adverse Reactions Leading to Discontinuation Treatment discontinuation due to an adverse reaction occurred in 1% (3/261) of patients receiving CLOTIC and 3% (4/132) of patients receiving placebo. Adverse reactions leading to discontinuation of CLOTIC were application site pain in two patients and tympanic membrane perforation in one patient.
Most Common Adverse Reactions Selected adverse reactions that occurred in 1 or more patients receiving CLOTIC are presented in Table 1. Table 1: Selected Adverse Reactions Occurring in 1 or more Patients in Trials 1 and 2 Adverse Reactions CLOTIC N=261 n (%) Placebo N=132 n (%) Headache 4 (1.5) 2 (1.5) Application site pain 2 (0.8) 0 Tinnitus 2 (0.8) 0 Tympanic membrane perforation 2 (0.8) 1 (0.8) Paresthesia 1 (0.4) 0
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Systemic absorption of clotrimazole following topical administration appears to be minimal, and maternal use of CLOTIC is not expected to result in fetal exposure to the drug. The background risk of major birth defects and miscarriage for the indicated population is unknown All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. 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.
8.2Lactation Risk Summary Systemic absorption following topical administration of CLOTIC appears to be minimal, and breastfeeding is not expected to result in exposure of the child to CLOTIC. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CLOTIC and any potential adverse effects on the breast-fed infant from CLOTIC or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of CLOTIC in pediatric patients less than 18 years of age have not been established.
8.5Geriatric Use Of the total number of patients with otomycosis who received CLOTIC in Trial 1 and Trial 2 (n=261), 78 (30%) were 65 years of age and older, while 23 (9%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Systemic absorption of clotrimazole following topical administration appears to be minimal, and maternal use of CLOTIC is not expected to result in fetal exposure to the drug. The background risk of major birth defects and miscarriage for the indicated population is unknown All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. 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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of CLOTIC in pediatric patients less than 18 years of age have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients with otomycosis who received CLOTIC in Trial 1 and Trial 2 (n=261), 78 (30%) were 65 years of age and older, while 23 (9%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Clotrimazole is an azole antifungal agent [see Microbiology (12.4) ] .
12.2Pharmacodynamics Clotrimazole exposure-response relationships and the time course of pharmacodynamic response are unknown.
12.3Pharmacokinetics Systemic absorption following topical administration of CLOTIC is anticipated to be minimal. The plasma concentrations of clotrimazole were not measured following otic installation of 1.7 mg (0.17 mL) clotrimazole 1% solution twice daily.
12.4Microbiology Mechanism of Action Clotrimazole, an azole antifungal agent, inhibits the cytochrome P450 dependent enzyme lanosterol 14-α-demethylase encoded by Erg11 in yeasts and Cyp51A in molds. Erg11/Cyp51A is necessary for the conversion of lanosterol to ergosterol, which is an essential sterol component of fungal cytoplasmic membrane. Disruption in ergosterol biosynthesis causes damage to the cell membrane by increasing its permeability, resulting in cell lysis and death.
Clotrimazole inhibition of lanosterol 14-α-demethylase also leads to an accumulation of 14-α-methylsterols; the methylsterols may affect the electron transport system, thereby inhibiting growth of fungi. Resistance Resistance to azoles, including clotrimazole, has been associated with decreased affinity for the target enzyme (Erg11 in Candida spp. and Cyp51A in Aspergillus spp.), increase in target copy number, alteration of the ergosterol biosynthetic pathway and overexpression of efflux pumps. Antimicrobial Activity CLOTIC has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections [see Indications and Usage (1) ] : Fungal Aspergillus spp.
Candida spp.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Clotrimazole is an azole antifungal agent [see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How supplied CLOTIC is a sterile otic solution of clotrimazole 1% packaged in low-density polyethylene (LDPE) single-dose vials with a deliverable volume of approximately 0.17 mL. The solution is clear colorless to slightly yellow. The vials are contained in an aluminum foil overwrap pouch and a carton box for protection from moisture.
Each carton box contains 2 foil pouches. Each pouch contains two strips of 7 single-dose vials. There are a total of 28 vials (NDC 15370-220-28).
Storage and Handling Store at 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature). Store unused vials in the foil pouch to protect from humidity.
Do not open foil pouch until ready to use. Discard vial after use. Discard unused vials 30 days after first opening the pouch.
📦 Storage and Handling ▾
Storage and Handling Store at 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature). Store unused vials in the foil pouch to protect from humidity. Do not open foil pouch until ready to use. Discard vial after use. Discard unused vials 30 days after first opening the pouch.
📋 Description ▾
11 DESCRIPTION CLOTIC is a sterile preservative-free otic solution containing clotrimazole, an azole antifungal agent, at a concentration of 1% in polyethylene glycol (PEG) 400. The solution is clear colorless to slightly yellow. Each single-dose vial of CLOTIC delivers approximately 0.17 mL of solution equivalent to 1.7 mg of clotrimazole.
Chemically, clotrimazole is 1-(o-chloro-α,α-diphenylbenzyl)imidazole, with the empirical formula C 22 H 17 ClN 2 , a molecular weight of 344.84, and the following structural formula. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Instructions Advise patients that CLOTIC is for otic use only. Advise patients to warm the otic solution by holding the vial in the hand for 1 to 2 minutes before instilling it in the ear, to avoid dizziness [see Dosage and Administration (2.2) ] .
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Systemic absorption following topical administration of CLOTIC is anticipated to be minimal. The plasma concentrations of clotrimazole were not measured following otic installation of 1.7 mg (0.17 mL) clotrimazole 1% solution twice daily.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Clotrimazole exposure-response relationships and the time course of pharmacodynamic response are unknown.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Osteoarthritis The effectiveness and safety of CLOTIC were evaluated in two phase 3, multicenter, randomized, double-blind, placebo-controlled trials in adult patients with unilateral or bilateral otomycosis and intact tympanic membranes (Trial 1, NCT03686384; Trial 2, NCT03686397). The treatment regimen consisted of instilling the contents of one single-dose vial of CLOTIC or placebo in the affected ear canal(s) twice daily for 14 consecutive days. Trial 1 was performed in the U.S. and Mexico; Trial 2 was performed in Europe.
Out of 394 patients randomized in Trial 1 and Trial 2, 228 had a positive baseline fungal culture for Aspergillus species and/or Candida species (mycological intent-to-treat [MITT] population). These patients had a median age of 53 years (range 19 to 89 years); 54% were male, 86% were White, and 28% were Hispanic or Latino ethnicity. Therapeutic cure was defined as both clinical cure and mycological cure at the test of cure visit which occurred on Day 24 to 26.
Clinical cure was defined as a total signs/symptoms score of zero on a 4 point scale for pruritis, otalgia, ear fullness, and otorrhea. Mycological cure was defined as eradication (culture does not show growth of any fungal pathogen) or presumed eradication (there is no material to culture and the overall clinical outcome is clinical cure). In both trials, CLOTIC demonstrated superiority to placebo in the MITT population for the proportion of patients with therapeutic cure.
The results for therapeutic cure (both clinical cure and mycological cure) for each trial are presented in Table 2: Table 2: Results of Therapeutic Cure in the MITT Population (Trials 1 and 2) Trial 1 Trial 2 CLOTIC N = 82 n (%) Placebo N = 36 n (%) CLOTIC N = 75 n (%) Placebo N = 35 n (%) Therapeutic Cure 48 (58.5) 10 (27.8) 59 (78.7) 8 (22.9) Treatment Difference (95% CI) 95% confidence interval for between-treatment group difference is based on Wald method 30.8 (12.7, 48.9) 55.8 (39.1, 72.5) p-value 0.0021 < 0.0001
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No long-term studies of CLOTIC have been performed to evaluate carcinogenic potential. A 78-week oral (dietary) study of clotrimazole in rats did not show evidence of carcinogenicity at doses up to an equivalent of 150 mg/kg/day. Mutagenesis Clotrimazole has been studied in in vitro (bacterial) and in vivo (hamster spermatogonia) mutagenicity assays, and no evidence of mutagenic potential was found.
Impairment of Fertility No reproduction toxicity studies were conducted with CLOTIC. Absorption of clotrimazole following topical administration is minimal.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No long-term studies of CLOTIC have been performed to evaluate carcinogenic potential. A 78-week oral (dietary) study of clotrimazole in rats did not show evidence of carcinogenicity at doses up to an equivalent of 150 mg/kg/day. Mutagenesis Clotrimazole has been studied in in vitro (bacterial) and in vivo (hamster spermatogonia) mutagenicity assays, and no evidence of mutagenic potential was found.
Impairment of Fertility No reproduction toxicity studies were conducted with CLOTIC. Absorption of clotrimazole following topical administration is minimal.
📄 Patient Package Insert ▾
PATIENT INFORMATION CLOTIC ['klↄtık] (clotrimazole) otic solution This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 10/2025 What is CLOTIC? CLOTIC is a prescription medicine used to treat adults 18 years of age and older with fungal infections in the ear called fungal otitis externa or otomycosis.
CLOTIC is used in the ear only (otic use) and contains clotrimazole, an antifungal agent. It is not known if CLOTIC is safe to use in people with ruptured eardrums (perforated tympanic membranes). It is not known if CLOTIC is safe and effective in children less than 18 years of age.
Do not use CLOTIC if you: are allergic to clotrimazole. See the end of this Patient Information leaflet for a complete list of ingredients in CLOTIC. Before using CLOTIC, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant.
It is not known if CLOTIC will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if CLOTIC can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with CLOTIC.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use CLOTIC? Read the detailed Instructions for Use that come with CLOTIC. Use CLOTIC exactly as your healthcare provider tells you to use it.
CLOTIC is for use in the ear only (otic use). CLOTIC comes as a liquid in single-dose vials. Warm the dose of CLOTIC by holding the vial in your hand for 1 to 2 minutes to prevent dizziness.
Apply the entire dose of CLOTIC from one single-dose vial, into the affected ear 2 times a day (for a total of 2 single-dose vials a day) for 14 days. Each dose should be about 12 hours apart. If your symptoms do not improve after 14 days of treatment with CLOTIC, call your healthcare provider.
What are the possible side effects of CLOTIC? The most common side effects of CLOTIC include: headache application site pain ruptured eardrum (perforation of the tympanic membrane) ringing in your ears (tinnitus) tingling, tickling or a burning sensation (paresthesia) These are not all the possible side effects of CLOTIC. 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 CLOTIC? Store the carton at room temperature between 68°F to 77°F (20°C to 25°C). Do not open the foil pouch until ready to use.
Keep unused vials in the foil pouch to protect from humidity. Throw away unused vials 30 days after first opening the pouch. When a vial is opened, use it right away and throw away (discard) the vial after use.
Keep CLOTIC and all medicines out of the reach of children. General information about the safe and effective use of CLOTIC. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
Do not use CLOTIC for a condition for which it was not prescribed. Do not give CLOTIC to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about CLOTIC that is written for health professionals. What are the ingredients in CLOTIC? Active ingredient: clotrimazole Inactive ingredient: polyethylene glycol 400 (PEG 400) Manufactured by: PHARMALOOP, S.L., Pol.
Industrial Azque – c/ Bolivia,15, Alcalá de Henares, 28806 MADRID Distributed by: Carwin Pharmaceutical Associates, LLC 1301 Hwy 36 - Suite 11, Hazlet, NJ 07730 USA Under license of Laboratorios Salvat, S.A. CLOTIC is a registered trademark of Laboratorios Salvat, S.A. For more information, go to www.carwinpharma.com or call 1-844-700-5011.
427492-01
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE CLOTIC ['klↄtık] (clotrimazole) otic solution This Instructions for Use contains information on how to use CLOTIC. Important Information You Need to Know Before Using CLOTIC: For otic use only (use in the ear). Use CLOTIC exactly as your healthcare provider tells you to use it.
Apply the entire dose of CLOTIC from 1 single-dose vial, into the affected ear 2 times a day (for a total of 2 single-dose vials a day) for 14 days. Each dose should be about 12 hours apart. Do not use CLOTIC after the expiration date (EXP) appearing on the outer carton, pouch and single-dose container.
The expiration date is the last day of that month, for example, 2025-DEC means the medicine expires December 31, 2025. Using CLOTIC Follow these instructions ( Step 1 to Step 11 ) each time you use CLOTIC. Ask your healthcare provider if there is anything you do not understand.
Step 1. Wash your hands with soap and water (Figure 1). Step 2.
Gently clean any fluid (discharge) from the outer ear using a clean cloth or tissue (Figure 2). Do not put a cotton swab or any other object in the ear canal. Step 3.
Remove CLOTIC from the protective foil pouch. Pull apart 1 single-dose vial of CLOTIC as shown, by tearing along the dotted lines (perforations) until it is fully separated (Figure 3). Place the unused vials back into the protective foil pouch Step 4.
Warm the dose of CLOTIC by holding the vial in your hand for 1 to 2 minutes (Figure 4). Step 5. Twist off the vial cap in the direction of the arrow as shown in Figure 5.
Step 6. The person receiving CLOTIC should be on his or her side with the affected ear up as shown in Figure 6. Step 7.
Hold the vial of CLOTIC in your hand and place the vial close to the ear. Let the entire dose of CLOTIC fall into the affected ear (Figure 7). Step 8.
Gently pull the outer ear lobe upward and outward (Figure 8). This will allow the ear drops to flow down into the ear canal. Step 9.
Remain on your side with the affected ear facing upward for 1 minute (Figure 9). Step 10. If your healthcare provider has told you to use CLOTIC in both ears, repeat Steps 2 to 9 in the other ear.
Step 11. Safely throw away CLOTIC vials after use. How should I store CLOTIC?
Store the carton at room temperature between 68°F to 77°F (20°C to 25°C). Do not open the foil pouch until ready to use. Keep unused vials in the foil pouch to protect from humidity.
Throw away unused vials 30 days after first opening the pouch. When a vial is opened, use it right away and throw away (discard) the vial after use. Keep CLOTIC and all medicines out of the reach of children.
Manufactured by: PHARMALOOP, S.L., Pol. Industrial Azque – c/ Bolivia,15, Alcalá de Henares, 28806 MADRID Distributed by: Carwin Pharmaceutical Associates, LLC 1301 Hwy 36 - Suite 11 Hazlet, NJ 07730 USA Under license of Laboratorios Salvat, S.A. This Instructions for Use has been approved by the U.S.
Food and Drug Administration. Approved: October 2025 Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 0.17 mL Vial Pouch Carton NDC 15370-220-28 Rx Only Clotic ® (clotrimazole) Otic solution 1% FOR USE IN THE EAR ONLY Sterile monodose Contents: 28 vials 0.17 mL each (Deliverable volume) carwin PHARMACEUTICAL ASSOCIATES Salvat PRINCIPAL DISPLAY PANEL - 0.17 mL Vial Pouch Carton
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