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Roxee Medication Guide

Ketoconazole

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

Both Reference partial Not FDA-approved for animals Rx required Multiple FDA labelers Official label facts Owner quick guide first
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Showing simplified owner view. Switch to Vet View for full technical detail.

Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:45 a.m.

Roxee has a partial reference profile for this medication. Some primary facts still need verification.

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 20, 2026, 8:54 p.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, 10:45 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • 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
Ketoconazole

Ketoconazole

Drug type: Generic ingredient • Branded profile • Not FDA-approved for animals

Both Rx required 87% reference complete

Species: Both

Approval status: Not FDA-approved as an animal drug. No FDA-approved animal-drug application is linked for this record. It may represent extra-label, human-drug, bulk-compounding, export-only, or otherwise unapproved animal-use source data; use only under veterinarian direction.

Medication Snapshot

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

Ketoconazole

Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus. Species commonly shown: Both.

Generic name
Ketoconazole
Brand names
KETOCONAZOLE, STRATFORD Keto-C TRIS FLUSH WITH CeraGuard, ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH, Truseb Antiseptic Tris Ear Flush for Dogs and Cats
Manufacturer
Multiple FDA labelers
Species
Both
Prescription
Prescription required
Completeness
87%
Validation
Incomplete
Brand names
KETOCONAZOLE STRATFORD Keto-C TRIS FLUSH WITH CeraGuard ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH Truseb Antiseptic Tris Ear Flush for Dogs and Cats Truseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses Forticept Antiseptic Ear Flush Suffusion TRIS firstCompanion TRIS FLUSH VETRASEB CERADERM TRIS Keto-C-Tris FLUSH TrizUltra Plus Keto Flush MySimplePetLab Infected Ear Relief Keto-C-Tris WIPES Paw Science MEDICATED EAR FLUSH CeraSoothe KET Vetericyn FoamCare Ketomax TRIS FLUSH Frisco Antiseptic Ear Flush T8 Keto Flush

Indications / Uses

Senvelgo (velagliflozin oral solution) is approved in cats for control of hyperglycemia associated with diabetes mellitus.

Side Effects

Top reported reactions (openFDA): Lack of efficacy - NOS, Vomiting, Other abnormal test result NOS, Diarrhoea, Lethargy (see also Central nervous system depression in 'Neurological'), INEFFECTIVE, ATOPY CONTROL.

FAQ

Both

Yes. Roxee shows this as prescription-only.

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Pet Owner Quick Guide

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

Roxee still has limited plain-language guidance for this medication. Use the official documents and your veterinarian's instructions for product-specific details.

Used for:

Your vet decides this. Here's what owners typically ask/watch for.

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:

  • wobbly/unsteady walking (1 reports)
  • Loss of appetite (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.

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 Ketoconazole; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-074363
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 22 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-074363
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-074363
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

Unsteady walking (ataxia) (1 reports), Loss of appetite (1 reports), Ear pain (1 reports), Ear canal erythema (1 reports), Dry mucous membrane (1 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (1), Neurologic (1), Behavior (1)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (19 reports), Cat (13 reports)

Breed metadata in reports Metadata only

Shepherd Dog - German (1), ['Pit Bull', 'Dog (unknown)'] (1), ['Retriever - Labrador', 'Mastiff (unspecified)'] (1), Bloodhound (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 Ketoconazole 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

wobbly/unsteady walking, Loss of appetite, 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 Ketoconazole 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-074363 · adverse_reaction · adverse reactions
  2. Structured Product Label · document · documents
  3. Structured Product Label · document · documents
  4. Structured Product Label · document · documents
  5. Structured Product Label · document · documents
  6. Structured Product Label · document · documents
  7. Structured Product Label · document · documents
  8. Structured Product Label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 15, 2026, 10:04 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • wobbly/unsteady walking
  • Loss of appetite
  • Ear pain

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Loss of appetite (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
Not linked yet
Indication / use
Your vet decides this. Here's what owners typically ask/watch for.
Form / route / dose
Confirm product label and patient-specific plan.
Warnings
No structured warnings linked yet.
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
Identifiers:
NDC Package: 11695-6973-1 NDC Package: 11695-6973-2 NDC Package: 11695-6973-3 NDC Package: 11695-6974-1 NDC Package: 11695-6975-1 NDC Package: 11695-6976-1 NDC Package: 11695-6979-1 NDC Package: 11695-6979-2 NDC Package: 13985-441-04 NDC Package: 13985-441-06 NDC Package: 13985-442-30 NDC Package: 13985-443-08 NDC Package: 13985-444-08 NDC Package: 13985-444-16 NDC Package: 13985-445-68 NDC Package: 17033-131-01 NDC Package: 17033-131-08 NDC Package: 17033-132-01 NDC Package: 17033-132-08 NDC Package: 17033-134-50

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
13
Matching reports
5
Active filters
2
Selected filters
Reaction: Lethargy (see also Central nervous system depression in Neurological) Clear Body system: Other Clear
Reset
Drill into common report signals
Leucopenia NOS (7) Lethargy (see also Central nervous system depression in Neurological) (5) Neutropenia (5) Anaemia NOS (3) Other (13) Neurologic (6) Digestive (5) Behavior (2)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-074795

Received 2025-12-20 · MSK · MSK

Serious
Species
Dog
Breed
['Pit Bull', 'Dog (unknown)']
Size / weight
50-99 lb (36.29 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)DiarrhoeaHaematuriaVomitingBasophiliaAnorexiaAdipsiaWheezingUnable to walkAtaxiaIncreased respiratory rateDry mucous membraneLeucopenia NOSPyrexiaLamenessBreathing difficultyReluctant to move
Body systems
NeurologicDigestiveOther
Outcomes
Ongoing

USA-USFDACVM-2025-US-074895

Received 2025-12-19 · MSK · MSK

Serious
Species
Dog
Breed
Bloodhound
Size / weight
50-99 lb (41.28 Kilogram)
Age
4-7 years (5 Year)
Sex
Female Neutered
Region
USA
Reactions
Lethargy (see also Central nervous system depression in Neurological)Stiffness NOSWalking difficultyGeneralised weaknessNeutropeniaLow platelet countPain NOSDecreased appetiteVomitingElevated liver enzymes NOSFluid in abdomen NOSLiver disorder NOSOther immune system disorder NOSFeverLeucopenia NOSDistension of abdomenHypoglycaemiaAnaemia NOSIndigestion
Body systems
NeurologicOtherDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-072729

Received 2025-12-05 · MSK · MSK

Non-serious
Species
Dog
Breed
Terrier - Bull
Size / weight
25-49 lb (17.6 Kilogram)
Age
4-7 years (7 Year)
Sex
Female Neutered
Region
USA
Reactions
Leucopenia NOSAnaemia NOSHypoalbuminaemiaNeutropeniaPyodermaReduced globulinsHypophosphataemiaNon-regenerative anaemiaLow serum alkaline phosphatase (ALP)Pale mucous membraneElevated alanine aminotransferase (ALT)Decreased packed cell volume (PCV)Lethargy (see also Central nervous system depression in Neurological)HypocalcaemiaElevated aspartate aminotransferase (AST)HypoproteinaemiaProteinuriaElectrolyte disorderDisorder of red blood cell NOSElevated creatine-kinase (CK)Other coagulation investigation abnormalityIncreased band neutrophiliaElevated mean corpuscular volume (MCV)LymphopeniaOther abnormal test result NOSDiarrhoeaPanleucopeniaEosinopeniaDecreased haematocritIncreased percentage reticulocytes
Body systems
OtherNeurologicDigestive
Outcomes
Ongoing

USA-USFDACVM-2025-US-074320

Received 2025-11-24 · MSK · MSK

Serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
25-49 lb (18.14 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Behavioural disorder NOSEpidermal collaretteHepatic toxicosisDermal thickeningPyodermaJoint swellingLocal swelling (not application site)Skin ulcerLethargy (see also Central nervous system depression in Neurological)ItchingHair loss NOSDeathInappetence
Body systems
BehaviorOtherSkin & allergyNeurologic
Outcomes
Died

USA-USFDACVM-2025-US-068424

Received 2025-11-17 · MSK · MSK

Serious
Species
Dog
Breed
['Terrier (unspecified)', 'Dog (unknown)']
Size / weight
25-49 lb (18.14 Kilogram)
Age
8+ years (9 Year)
Sex
Male Neutered
Region
USA
Reactions
Behavioural disorder NOSEpidermal collaretteHepatic toxicosisDermal thickeningPyodermaJoint swellingLocal swelling (not application site)Skin ulcerLethargy (see also Central nervous system depression in Neurological)ItchingHair loss NOSDeathInappetence
Body systems
BehaviorOtherSkin & allergyNeurologic
Outcomes
Died

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

Tracked signals
32
Reported cases
32
Serious reports
22
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Diarrhea, Decreased appetite Skin & allergy (1) · Application site itching Neurologic (1) · Unsteady walking (ataxia) Behavior (1) · Behavioral disorder (unspecified) Other (26) · Ear pain, Ear canal erythema, Dry mucous membrane
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Digestive 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Dog (19) Cat (13)

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

Truseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses SPL SPL · Structured Product Label Truseb Antiseptic Tris Ear Flush for Dogs and Cats SPL SPL · Structured Product Label ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH SPL SPL · Structured Product Label

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

20

FOI

0
No FOI links yet.

Truseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Truseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses. Use the source link for the full official labeling record.

Truseb Antiseptic Tris Ear Flush for Dogs and Cats SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Truseb Antiseptic Tris Ear Flush for Dogs and Cats. Use the source link for the full official labeling record.

ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH. Use the source link for the full official labeling record.

STRATFORD Keto-C TRIS FLUSH WITH CeraGuard SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for STRATFORD Keto-C TRIS FLUSH WITH CeraGuard. Use the source link for the full official labeling record.

KETOCONAZOLE SPL

SPL · Structured Product Label

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

T8 Keto Flush SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for T8 Keto Flush. Use the source link for the full official labeling record.

Frisco Antiseptic Ear Flush SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Frisco Antiseptic Ear Flush. Use the source link for the full official labeling record.

Keto-C-Tris FLUSH SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Keto-C-Tris FLUSH. Use the source link for the full official labeling record.

Ketomax TRIS FLUSH SPL

SPL · Structured Product Label

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

MySimplePetLab Infected Ear Relief SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for MySimplePetLab Infected Ear Relief. Use the source link for the full official labeling record.

TrizUltra Plus Keto Flush SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for TrizUltra Plus Keto Flush. Use the source link for the full official labeling record.

Suffusion TRIS SPL

SPL · Structured Product Label

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

ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH. Use the source link for the full official labeling record.

Vetericyn FoamCare SPL

SPL · Structured Product Label

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

CeraSoothe KET SPL

SPL · Structured Product Label

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

Paw Science MEDICATED EAR FLUSH SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Paw Science MEDICATED EAR FLUSH. Use the source link for the full official labeling record.

Keto-C-Tris WIPES SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Keto-C-Tris WIPES. Use the source link for the full official labeling record.

VETRASEB CERADERM TRIS SPL

SPL · Structured Product Label

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

firstCompanion TRIS FLUSH SPL

SPL · Structured Product Label

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

Forticept Antiseptic Ear Flush SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Forticept Antiseptic Ear Flush. Use the source link for the full official labeling record.
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, 10:45 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • 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: ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH CeraSoothe KET Forticept Antiseptic Ear Flush Frisco Antiseptic Ear Flush KETOCONAZOLE Keto-C-Tris FLUSH Keto-C-Tris WIPES Ketomax TRIS FLUSH MySimplePetLab Infected Ear Relief Paw Science MEDICATED EAR FLUSH STRATFORD Keto-C TRIS FLUSH WITH CeraGuard Suffusion TRIS T8 Keto Flush TrizUltra Plus Keto Flush Truseb Antiseptic Tris Ear Flush for Dogs and Cats Truseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses VETRASEB CERADERM TRIS Vetericyn FoamCare firstCompanion TRIS FLUSH
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both
NDC: Packages 11695-6979-1 11695-6979-2 13985-441-04 13985-441-06 17033-239-04 17033-239-12 • Products 11695 13985 17033 46066 58198 68898
Safety (openFDA)
Top reactions: Dog 91 • Cat 0 • View
Case summaries: 13 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

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

Top reaction signals
Unsteady walking (ataxia) (1) Loss of appetite (1) Ear pain (1) Ear canal erythema (1) Dry mucous membrane (1) Dry heaving (1) Distension of abdomen (1) Difficulty eating NOS (1)

Identifiers & Packages

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

Identifiers
NDC Package: 11695-6973-1 NDC Package: 11695-6973-2 NDC Package: 11695-6973-3 NDC Package: 11695-6974-1 NDC Package: 11695-6975-1 NDC Package: 11695-6976-1 NDC Package: 11695-6979-1 NDC Package: 11695-6979-2 NDC Package: 13985-441-04 NDC Package: 13985-441-06 NDC Package: 13985-442-30 NDC Package: 13985-443-08 NDC Package: 13985-444-08 NDC Package: 13985-444-16 NDC Package: 13985-445-68 NDC Package: 17033-131-01 NDC Package: 17033-131-08 NDC Package: 17033-132-01 NDC Package: 17033-132-08 NDC Package: 17033-134-50 NDC Package: 17033-142-02 NDC Package: 17033-142-08 NDC Package: 17033-143-08 NDC Package: 17033-191-04
Package NDC Product NDC Form / Route Status
11695-6973-1 11695 -
11695-6973-2 11695 -
11695-6973-3 11695 -
11695-6974-1 11695 -
11695-6975-1 11695 -
11695-6976-1 11695 -
11695-6979-1 11695 -
11695-6979-2 11695 -
13985-441-04 13985 -
13985-441-06 13985 -
13985-442-30 13985 -
13985-443-08 13985 -
13985-444-08 13985 -
13985-444-16 13985 -
13985-445-68 13985 -
17033-131-01 17033 -
17033-131-08 17033 -
17033-132-01 17033 -
17033-132-08 17033 -
17033-134-50 17033 -

Enriched Documents

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

  • Truseb Ketoconazole Tris Ear Flush for Dogs, Cats and Horses SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Truseb Antiseptic Tris Ear Flush for Dogs and Cats SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • STRATFORD Keto-C TRIS FLUSH WITH CeraGuard SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • KETOCONAZOLE SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • T8 Keto Flush SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Frisco Antiseptic Ear Flush SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Keto-C-Tris FLUSH SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Ketomax TRIS FLUSH SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • MySimplePetLab Infected Ear Relief SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • TrizUltra Plus Keto Flush SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Suffusion TRIS SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Vetericyn FoamCare SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • CeraSoothe KET SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Paw Science MEDICATED EAR FLUSH SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Keto-C-Tris WIPES SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • VETRASEB CERADERM TRIS SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • firstCompanion TRIS FLUSH SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Forticept Antiseptic Ear Flush SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.

Data Sources & Change Log

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

Official 133 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, Vomiting, Other abnormal test result NOS, Diarrhoea, Lethargy (see also Central nervous system depres… (Clinical, 2026-04-11)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-22)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-22)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-21)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-20)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-13)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-12)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-12)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-11)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-11)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-10)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-09)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-08)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-06-07)
Recent Revisions
  • side_effects updated 2026-06-22 10:45 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-22 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-21 05:18 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-20 20:58 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-13 11:33 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-12 10:42 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-12 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-11 19:22 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-11 18:40 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-10 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-08 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-07 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-06 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-04 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-01 10:40 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-06-01 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-05-31 10:05 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

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

Product Sponsor Application Status Published

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

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) • Dog Diarrhea (1) • Dog Decreased appetite (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Application site itching (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
Ear pain (1) • Cat Ear canal erythema (1) • Cat Dry mucous membrane (1) • Dog Dry heaving (1) • Cat Distension of abdomen (1) • Dog
Show more (21)
Disorder of red blood cell NOS (1) • Dog Difficulty eating NOS (1) • Cat Dermal thickening (1) • Dog Dehydration (1) • Cat Decreased red blood cell count (1) • Dog Decreased packed cell volume (1) • Dog Decreased haematocrit (1) • Dog Decreased drinking (1) • Cat Decreased bowel movements (1) • Cat Death (1) • Dog Breathing difficulty (1) • Dog Brain damage NOS (1) • Cat Bradycardia (1) • Dog Basophilia (1) • Dog Balance problem (1) • Cat Application site reddening (1) • Cat Application site inflammation (1) • Cat Application site erythema (1) • Cat Anaemia NOS (1) • Dog Adipsia (1) • Dog Active urine sediment (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.

Dog, Shepherd Dog - German, Female, 10.9 year, 44.45 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Lack of efficacy - NOS, Seizure NOS, Other abnormal test result NOS, Unsteady walking (ataxia), Musculoskeletal disorder NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075291
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 10.90 Year
  • Weight: 44.450 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Lack of efficacy - NOS Seizure NOS Other abnormal test result NOS Unsteady walking (ataxia) Musculoskeletal disorder NOS Elevated serum alkaline phosphatase
Outcomes: Ongoing

Dog, ['Pit Bull', 'Dog (unknown)'], Female, 5 year, 36.29 kilogram • Drug: MSK, Unknown • Reactions: Tiredness (lethargy), Diarrhea, Haematuria, Vomiting, Basophilia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074795
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 36.290 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Tiredness (lethargy) Diarrhea Haematuria Vomiting Basophilia Loss of appetite Adipsia Wheezing Unable to walk Unsteady walking (ataxia) Increased respiratory rate Dry mucous membrane Leucopenia NOS Fever Lameness Breathing difficulty Reluctant to move
Outcomes: Ongoing

Dog, ['Retriever - Labrador', 'Mastiff (unspecified)'], Male, 8 year, 57.606 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Falling, Lateral recumbency, Vomiting • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075362
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 57.606 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Falling Lateral recumbency Vomiting
Outcomes: Ongoing

Dog, Bloodhound, Female, 5 year, 41.28 kilogram • Drug: MSK, Oral, Dose: 400 Milligram per animal, Frequency: 1 per day • Reactions: Tiredness (lethargy), Stiffness NOS, Walking difficulty, Generalised weakness, Neutropenia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074895
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 41.280 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Dose: 400 Milligram per animal
  • Frequency: 1 per day
Reactions Reported:
Tiredness (lethargy) Stiffness NOS Walking difficulty Generalised weakness Neutropenia Low platelet count Pain NOS Decreased appetite Vomiting Elevated liver enzymes NOS Fluid in abdomen NOS Liver disorder NOS Other immune system disorder NOS Fever Leucopenia NOS Distension of abdomen Hypoglycaemia Anaemia NOS Indigestion
Outcomes: Ongoing

Dog, Crossbred Canine/dog, Male, 5 year, 17.32 kilogram • Drug: MSK, Unknown • Reactions: Weight loss, Decreased red blood cell count, Leucopenia NOS, Anaemia NOS, Lymphopenia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074810
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 17.320 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Weight loss Decreased red blood cell count Leucopenia NOS Anaemia NOS Lymphopenia Increased percentage reticulocytes
Outcomes: Ongoing

Dog, Bichon Frise, Male, 5 year, 7.71 kilogram • Drug: MSK, Unknown • Reactions: Leucopenia NOS, Neutropenia • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074706
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 7.710 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Leucopenia NOS Neutropenia
Outcomes: Ongoing

Dog, Retriever - Labrador, Male, 11.3 year, 37.8 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Wound, Lick granuloma, External ear disorder NOS, Perianal inflammation, Musculoskeletal disorder NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074363
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 11.30 Year
  • Weight: 37.800 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Wound Lick granuloma External ear disorder NOS Perianal inflammation Musculoskeletal disorder NOS Heavy breathing Panting Decreased appetite Scooting Active urine sediment Fungal skin infection NOS Skin lesion NOS Lack of efficacy - NOS
Outcomes: Ongoing

Dog, Terrier - Bull, Female, 7 year, 17.6 kilogram • Drug: MSK, Oral, Dose: 1 tablet per animal, Frequency: 1 per day • Reactions: Leucopenia NOS, Anaemia NOS, Hypoalbuminaemia, Neutropenia, Pyoderma… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072729
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 17.600 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Dose: 1 tablet per animal
  • Frequency: 1 per day
Reactions Reported:
Leucopenia NOS Anaemia NOS Hypoalbuminaemia Neutropenia Pyoderma Reduced globulins Hypophosphataemia Non-regenerative anaemia Low serum alkaline phosphatase Pale mucous membrane Elevated alanine aminotransferase Decreased packed cell volume Tiredness (lethargy) Hypocalcaemia Elevated aspartate aminotransferase Hypoproteinaemia Proteinuria Electrolyte disorder Disorder of red blood cell NOS Elevated creatine-kinase Other coagulation investigation abnormality Increased band neutrophilia Elevated mean corpuscular volume Lymphopenia Other abnormal test result NOS Diarrhea Panleucopenia Eosinopenia Decreased haematocrit Increased percentage reticulocytes
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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