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Roxee Medication Guide

Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Solution Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Jun 13, 2026, 11:29 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed May 1, 2026, 10:01 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Image coming soon
Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate

Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Solution Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate

CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). Species commonly shown: Both, Dog.

Generic name
Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate
Brand names
CLARO™, SIMPLERA™, Klentz™, Florfinasone™ Otic
Manufacturer
Multiple FDA labelers
Species
Both, Dog
Dosage forms
Solution
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
CLARO™ SIMPLERA™ Klentz™ Florfinasone™ Otic Klentz SIMPLERA Otic Solution Claro
Dosage forms
Solution

Indications / Uses

CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).

Warnings / Contraindications

For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Ear discharge, Ataxia, Head shake - ear disorder, Otorrhoea, Lethargy (see also Central nervous system depression in 'Neurological').

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Solution

Related Conditions

Otitis Externa (Ear Infection)

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

Florfinasone™ Otic is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • For otic use in dogs only
  • Loss of appetite (1 reports)
  • itchy skin (1 reports)
  • Ear pain (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-072174
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 17 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-072174
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-072174
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Loss of appetite (1 reports), Ear pruritus (1 reports), Ear pain (1 reports), Ear discharge (1 reports), Ear canal erythema (1 reports)

Body systems represented Signal grouping

Digestive (4), Skin & allergy (2), Neurologic (2), Behavior (2)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (23 reports), Cat (9 reports)

Breed metadata in reports Metadata only

American Shorthair (1), Beagle (1), ['Retriever - Golden', 'Poodle (unspecified)'] (1), Dachshund (unspecified) (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

For otic use in dogs only, Loss of appetite, itchy skin, Ear pain

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-072174 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 22, 2026, 10:06 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • For otic use in dogs only
  • Loss of appetite
  • itchy skin
  • Ear pain

Most reported reactions:

  • Loss of appetite (1 reports)
  • Ear pruritus (1 reports)
  • Ear pain (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
Florfinasone™ Otic is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus…
Form / route / dose
Form: Solution
Route: Otic
Confirm product label and patient-specific plan.
Warnings
  • High: For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA labelers
Form: Solution
Identifiers:
ANADA: 200719 ANADA: 200829 ANADA: 200848 NADA: 141440 NDC Package: 17030-001-10 NDC Package: 51072-122-00 NDC Package: 51072-122-01 NDC Package: 51072-122-02 NDC Package: 58198-0027-1 NDC Package: 58198-0027-2 NDC Package: 58198-0027-3 NDC Package: 58198-0027-4 NDC Package: 86136-125-67 NDC Product: 17030 NDC Product: 51072 NDC Product: 58198 NDC Product: 86136
Source metadata:

Warnings / Contraindications

For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
12
Matching reports
1
Active filters
2
Selected filters
Reaction: Third eyelid protrusion Clear Body system: Digestive Clear
Reset
Drill into common report signals
Third eyelid protrusion (4) Ataxia (3) Lack of efficacy - NOS (3) Nystagmus (3) Other (11) Neurologic (5) Digestive (3) Effectiveness (3)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-068768

Received 2025-11-14 · MSK · MSK

Serious
Species
Cat
Breed
Domestic Mediumhair
Size / weight
Under 10 lb (4.13 Kilogram)
Age
1-3 years (2 Year)
Sex
Female Neutered
Region
USA
Reactions
AnorexiaReluctant to moveVocalisationLoss of bowel controlNot urinatingEosinopeniaBasophiliaHypernatremiaThrombocytopeniaAbnormal radiograph findingThird eyelid protrusionOther ear disorder NOS
Body systems
DigestiveOther
Outcomes
Ongoing

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
17
Species represented
2
Grouped by Body System
Digestive (4) · Loss of appetite, Diarrhea, Decreased appetite Skin & allergy (2) · Hair loss, Ear pruritus Neurologic (2) · Unsteady walking (ataxia), Circling - neurological disorder Behavior (2) · Circling - behavioural disorder, Behavioral disorder (unspecified) Other (22) · Elevated temperature, Ear pain, Ear discharge
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Cat 1
Skin & allergy 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Digestive 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (23) Cat (9)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Dog Non-serious - 1
Digestive Cat Serious - 1
Skin & allergy Dog Non-serious - 1
Other Dog Non-serious - 1
Skin & allergy Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Digestive Dog Serious - 1
Digestive Cat Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Neurologic Cat Non-serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Digestive Dog Non-serious - 1
Behavior Dog Non-serious - 1
Other Cat Serious - 1
Other Cat Non-serious - 1
Other Dog Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Florfinasone™ Otic SPL · SPL Klentz™ SPL · SPL SIMPLERA™ SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

8

FOI

4

Florfinasone™ Otic

SPL · SPL

Open original
FDA Structured Product Label

Florfinasone™ Otic

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-848
Status
RX
Form
Solution
Route
Otic
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate

Dogs

Indication

Florfinasone™ Otic is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

Klentz™

SPL · SPL

Open original
FDA Structured Product Label

Klentz™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Aurora Pharmaceutical, Inc.
ANADA
200-829
Status
RX
Form
Solution
Route
Otic
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate

Dogs

Indication

For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

SIMPLERA™

SPL · SPL

Open original
FDA Structured Product Label

SIMPLERA™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Vetoquinol USA, Inc.
ANADA
200-719
Status
RX
Form
Solution
Route
Otic
Species
Dog
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate

Dogs

Indication

For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

CLARO™

SPL · SPL

Open original
FDA Structured Product Label

CLARO™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
141-440
Status
RX
Form
Solution
Route
Otic
Species
Dog
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride), 2.2 mg/mL mometasone furoate

Dogs

Indication

CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage
Administer one dose (1 dropperette) per affected ear. The duration of effect should last 30 days.
Limitations
For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Klentz SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Klentz. Use the source link for the full official labeling record.

Claro SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Claro. Use the source link for the full official labeling record.

SIMPLERA Otic Solution SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for SIMPLERA Otic Solution. Use the source link for the full official labeling record.

SIMPLERA Otic Solution SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for SIMPLERA Otic Solution. Use the source link for the full official labeling record.

FOI Summary oA 200-848 Approved April 8, 2026.pdf

FOI · FOI

Open original

FOI Summary oA 200-829 Approved December 22, 2025.pdf

FOI · FOI

Open original

FOI Summary oA 200-719 Approved September 28, 2022.pdf

FOI · FOI

Open original

UCM465253.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed May 1, 2026, 10:01 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Claro Klentz SIMPLERA Otic Solution
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Solution • Otic
Applications: ANADA 200-848 • ANADA 200-829 • ANADA 200-719 • NADA 141-440
NDC: Packages 17030-001-10 51072-122-00 51072-122-01 51072-122-02 58198-0027-1 58198-0027-2 • Products 17030 51072 58198 86136
Documents: 4 (FOI: 4) • SPL: 4 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 25 • Cat 32 • View
Case summaries: 12 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Otitis Externa (Ear Infection)
Linked using: Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: H60.90
Otitis externa, unspecified ear

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Loss of appetite (1) Ear pruritus (1) Ear pain (1) Ear discharge (1) Ear canal erythema (1) Dry nose (1) Diarrhea (1) Death (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200719 ANADA: 200829 ANADA: 200848 NADA: 141440 NDC Package: 17030-001-10 NDC Package: 51072-122-00 NDC Package: 51072-122-01 NDC Package: 51072-122-02 NDC Package: 58198-0027-1 NDC Package: 58198-0027-2 NDC Package: 58198-0027-3 NDC Package: 58198-0027-4 NDC Package: 86136-125-67 NDC Product: 17030 NDC Product: 51072 NDC Product: 58198 NDC Product: 86136
Package NDC Product NDC Form / Route Status
17030-001-10 17030 -
51072-122-00 51072 -
51072-122-01 51072 -
51072-122-02 51072 -
58198-0027-1 58198 -
58198-0027-2 58198 -
58198-0027-3 58198 -
58198-0027-4 58198 -
86136-125-67 86136 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 121 Clinical 7 Manufacturer 0 Marketing 0
Current Field Facts
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-21)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-20)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-19)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Ear discharge, Ataxia, Head shake - ear disorder, Otorrhoea, Lethargy (see also Central nervous syste… (Clinical, 2026-04-11)
  • contraindications: For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-22)
  • dosage_forms: Solution (Official, 2026-06-22)
  • dosage_forms: Solution (Official, 2026-06-22)
  • dosage_forms: Solution (Official, 2026-06-21)
  • dosage_forms: Solution (Official, 2026-06-20)
  • dosage_forms: Solution (Official, 2026-06-13)
  • dosage_forms: Solution (Official, 2026-06-12)
  • dosage_forms: Solution (Official, 2026-06-12)
  • dosage_forms: Solution (Official, 2026-06-11)
  • dosage_forms: Solution (Official, 2026-06-11)
  • dosage_forms: Solution (Official, 2026-06-10)
  • dosage_forms: Solution (Official, 2026-06-09)
  • dosage_forms: Solution (Official, 2026-06-08)
Recent Revisions
  • side_effects updated 2026-04-22 10:06 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:06 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:06 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-21 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-21 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-21 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-21 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-21 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-21 10:07 by curated_loader • Official FDA application reference for Senvelgo.
  • monitoring updated 2026-04-20 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-20 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-20 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-20 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-20 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-20 10:08 by curated_loader • Official FDA application reference for Senvelgo.
  • monitoring updated 2026-04-19 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-19 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-19 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-19 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-19 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Florfinasone™ Otic
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-848 Approved Apr 30, 2026
Klentz™
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Aurora Pharmaceutical, Inc. ANADA 200-829 Approved Jan 5, 2026
SIMPLERA™
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Vetoquinol USA, Inc. ANADA 200-719 Approved Oct 3, 2022
CLARO™
RX
Florfenicol Mometasone furoate Terbinafine
Solution • Otic
Label highlights
Official documents
Elanco US Inc. NADA 141-440 Approved Aug 3, 2021

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate
Dogs
Indication

Florfinasone™ Otic is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

Limitations

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate
Dogs
Indication

For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate
Dogs
Indication

For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage

Administer one dose (1 dropperette) per affected ear.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog
Composition / specifications
16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine (equivalent to 16.6 mg/mL terbinafine hydrochloride), 2.2 mg/mL mometasone furoate
Dogs
Indication

CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

Dosage
Administer one dose (1 dropperette) per affected ear. The duration of effect should last 30 days.
Limitations
For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ). For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Cat Diarrhea (1) • Dog Decreased appetite (1) • Cat Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog Ear pruritus (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Circling - neurological disorder (1) • Cat

Showing top 5 for Neurologic.

Behavior
Circling - behavioural disorder (1) • Dog Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
Elevated temperature (1) • Dog Ear pain (1) • Dog Ear discharge (1) • Dog Ear canal erythema (1) • Dog Dull (1) • Dog
Show more (17)
Dry nose (1) • Dog Dilated pupils (1) • Dog Death (1) • Dog Deafness (1) • Dog Crust (1) • Dog Cough (1) • Cat Corneal ulcer (1) • Dog Corneal disorder NOS (1) • Dog Bruising (1) • Dog Basophilia (1) • Cat Balance problem (1) • Cat Bacterial skin infection NOS (1) • Dog Anisocoria (1) • Cat Agitation (1) • Dog Adipsia (1) • Cat Abnormal radiograph finding (1) • Cat Abnormal cytology (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Cat, American Shorthair, Female, 4.83 year, 4.5 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 0.50 tube per animal • Reactions: Not eating, Walking difficulty, Falling, Unable to stand, Anisocoria… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074692
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 4.83 Year
  • Weight: 4.500 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 0.50 tube per animal
Reactions Reported:
Not eating Walking difficulty Falling Unable to stand Anisocoria Third eyelid protrusion
Outcomes: Ongoing

Dog, Beagle, Male, 9 year, 15.14 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal, Frequency: 1 per month • Reactions: Keratoconjunctivitis sicca, Lack of efficacy - NOS, Ocular discharge • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073850
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 15.140 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 tube per animal
  • Frequency: 1 per month
Reactions Reported:
Keratoconjunctivitis sicca Lack of efficacy - NOS Ocular discharge
Outcomes: Ongoing

Dog, ['Retriever - Golden', 'Poodle (unspecified)'], Male, 2.66 year, 19.95 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal • Reactions: Dull, Stumbling gait, Dilated pupils, Falling, High blood pressure… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074176
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.66 Year
  • Weight: 19.950 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Dull Stumbling gait Dilated pupils Falling High blood pressure Elevated temperature Unsteady walking (ataxia) Unsteady gait
Outcomes: Ongoing

Dog, Dachshund (unspecified), Male, 13 year, 7.8 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal • Reactions: Head tilt - ear disorder, Vestibular disorder NOS, Nystagmus • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073475
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 7.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Head tilt - ear disorder Vestibular disorder NOS Nystagmus
Outcomes: Ongoing

Dog, Poodle (unspecified), Male • Drug: MSK, Solution, Auricular (Otic), Dose: 2 tube per animal • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075060
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 2 tube per animal
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Shepherd Dog - Australian, Male, 4 year, 12.24 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal • Reactions: Horizontal nystagmus, Squinting, Ocular discharge, Head tilt - ear disorder, Low tear flow… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-073860
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 4.00 Year
  • Weight: 12.240 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 tube per animal
Reactions Reported:
Horizontal nystagmus Squinting Ocular discharge Head tilt - ear disorder Low tear flow Unsteady walking (ataxia) Head shake - ear disorder
Outcomes: Ongoing

Dog, Shepherd Dog - German, Female, 12.5 year, 27.44 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 tube per animal, Frequency: 5 per week • Reactions: Deafness • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072408
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 12.50 Year
  • Weight: 27.440 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 tube per animal
  • Frequency: 5 per week
Reactions Reported:
Deafness
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 11 year, 8 kilogram • Drug: MSK, Solution, Auricular (Otic), Dose: 1 mL per animal • Reactions: Miosis, Third eyelid protrusion, Hiding, Wobbliness • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-070809
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.00 Year
  • Weight: 8.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Solution
  • Dose: 1 mL per animal
Reactions Reported:
Miosis Third eyelid protrusion Hiding Wobbliness
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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