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

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

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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

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

Verified source: https://www.roxee.ai/meds/
Verified source: https://animaldrugsatfda.fda.gov
Verified source: https://animaldrugsatfda.fda.gov/adafda/views/#/search
Verified source: https://api.fda.gov/animalandveterinary/event.json
Verified source: https://www.roxee.ai/conditions/
Verified source: https://www.accessdata.fda.gov/spl/data/70e46314-31b1-4bf8-a5cb-a9bf68330df1/70e46314-31b1-4bf8-a5cb-a9bf68330df1.xml
Last refreshed: Jun 22, 2026, 10:41 a.m.
Last verified: Apr 22, 2026, 10:06 a.m.
Validation status: Needs review

Add to My Pet's Medications

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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

openFDA case USA-USFDACVM-2025-US-072174 · adverse_reaction · adverse reactions
Contraindication source · fda_animal_drugs · warnings contraindications
FDA application profile · official_label · quick facts
FDA application profile · official_label · quick facts
Medication usage source · fda_animal_drugs · quick facts
FOI · document · documents
SPL · document · documents
FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

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

Sources:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
SIMPLERA™ · official_label
openFDA case USA-USFDACVM-2025-US-072174 · adverse_reaction

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:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200848 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200829 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

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:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

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

Matching reports

Active filters

Selected filters

Reaction: Lack of efficacy - NOS Clear Body system: Digestive Clear

Species

Breed

Size / weight

Age

Sex

Seriousness

Outcome

Reaction

Body system

Region

Received after

Received before

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.

CAN-USFDACVM-2025-CA-000114

Received 2025-11-20 · MSK · MSK

Serious

Species: Dog
Breed: ['Poodle (unspecified)', 'Retriever - Golden']
Size / weight: 25-49 lb (20.1 Kilogram)
Age: Under 1 year (9 Month)
Sex: Male Intact
Region: USA
Reactions: Lack of efficacy - NOSDiarrhoeaEar painEar canal erythemaEar dischargeHead shake - ear disorderCircling - behavioural disorder (see also Neurological disorders)Ear pruritus
Body systems: EffectivenessDigestiveOtherNeurologicSkin & allergy
Outcomes: Outcome Unknown

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

Tracked signals

Reported cases

Serious reports

Species represented

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

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

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:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-072174

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

No owner handouts linked yet.

Official label / PI

No official label or package insert links yet.

SPL

FOI

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:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18375 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18629/Florfinasone%E2%84%A2%20Otic · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17828 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/18162/Klentz%E2%84%A2 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/12934 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/13011/SIMPLERA%E2%84%A2 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/931 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2303/CLARO%E2%84%A2 · document · SPL
https://www.accessdata.fda.gov/spl/data/e7dc83e2-4c6c-4497-acbe-c9d33b5ad6be/e7dc83e2-4c6c-4497-acbe-c9d33b5ad6be.xml · document · Structured Product Label
https://www.accessdata.fda.gov/spl/data/70e46314-31b1-4bf8-a5cb-a9bf68330df1/70e46314-31b1-4bf8-a5cb-a9bf68330df1.xml · document · Structured Product Label

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

Package NDC	Product NDC	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.

Klentz SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
Claro SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
SIMPLERA Otic Solution SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
SIMPLERA Otic Solution SPL • Structured Product Label • Official
FDA Structured Product Label from the electronic animal drug product listing directory.
FOI Summary oA 200-848 Approved April 8, 2026.pdf • FOI summary • Official • April 30, 2026
FDA FOI summary for application 200848
FOI Summary oA 200-829 Approved December 22, 2025.pdf • FOI summary • Official • Jan. 5, 2026
FDA FOI summary for application 200829
FOI Summary oA 200-719 Approved September 28, 2022.pdf • FOI summary • Official • Oct. 3, 2022
FDA FOI summary for application 200719
UCM465253.pdf • FOI summary • Official • Aug. 3, 2021
FDA FOI summary for application 141440

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

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

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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Medical Disclaimer: The medication details provided on Roxee are for informational purposes only and are not a substitute for professional veterinary advice. Always consult your veterinarian about your pet's specific needs.

Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate

Data freshness

Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate

Medication Snapshot

Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate

Indications / Uses

Warnings / Contraindications

Side Effects

FAQ

What species is this commonly shown for?

Does this usually require a prescription?

What dosage forms are listed?

Related Conditions

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What to watch next

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Reported case explorer

CAN-USFDACVM-2025-CA-000114

Grouped by Body System

Most Reported Reactions

Source Documents

Owner handouts

Official label / PI

SPL

FOI

Florfinasone™ Otic

Florfinasone™ Otic

Dogs

Klentz™

Klentz™

Dogs

SIMPLERA™

SIMPLERA™

Dogs

CLARO™

CLARO™

Dogs

Klentz SPL

Claro SPL

SIMPLERA Otic Solution SPL

SIMPLERA Otic Solution SPL

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

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

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

UCM465253.pdf

At a Glance

Counseling and Monitoring Highlights

Identifiers & Packages

Enriched Documents

Data Sources & Change Log

FDA Products & Applications (Animal Drugs @ FDA)

What It's For (FDA Label Highlights)

Florfinasone™ Otic • Solution • Otic

Klentz™ • Solution • Otic

SIMPLERA™ • Solution • Otic

CLARO™ • Solution • Otic

Usage

Contraindications

Top Reported Reactions (openFDA)

Adverse Event Case Summaries (openFDA)

Dec 18, 2025 • Cat • American Shorthair • Not eating, Walking difficulty • Ongoing

Dec 17, 2025 • Dog • Beagle • Keratoconjunctivitis sicca, Lack of efficacy - NOS • Ongoing

Dec 16, 2025 • Dog • ['Retriever - Golden', 'Poodle (unspecified)'] • Dull, Stumbling gait • Ongoing

Dec 15, 2025 • Dog • Dachshund (unspecified) • Head tilt - ear disorder, Vestibular disorder NOS • Ongoing

Dec 11, 2025 • Dog • Poodle (unspecified) • Lack of efficacy - NOS • Outcome Unknown

Dec 10, 2025 • Dog • Shepherd Dog - Australian • Horizontal nystagmus, Squinting • Ongoing

Dec 10, 2025 • Dog • Shepherd Dog - German • Deafness • Ongoing