Meds A-Z
Mometasone
Detailed information about Mometasone
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).
What it does:
For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aeruginosa ], coagulase-positive staphylococci, Enterococcus faecal...
When it's needed:
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.
Call your vet sooner if you notice:
- 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.
Commonly reported reactions:
- (1 reports)
- (1 reports)
- (1 reports)
What to 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?
Mometasone
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200829 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141177 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
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.
- High: 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.
- 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.
Tap or hover a reaction to see what it means in plain language.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 0 | |
| 1 | Cat | 0 | |
| 1 | Dog | 0 | |
| 1 | Cat | 0 |
Species coverage: Cat (17) Dog (15)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2024-US-077320
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 16 • Secondary summaries: 0
- FOI Summary oA 200-829 Approved December 22, 2025.pdf · FOI
- Klentz™ · SPL
- ucm117269.pdf · FOI
- ucm117268.pdf · FOI
- ucm117265.pdf · FOI
- Mometamax™ Otic Suspension · SPL
- FOI Summary oN 141-600 Approved April 29 2025_ef.pdf · FOI
- Mometamax Single™ · SPL
- FOI Summary oA 200-719 Approved September 28, 2022.pdf · FOI
- SIMPLERA™ · SPL
- UCM465253.pdf · FOI
- CLARO™ · SPL
- UCM256757.pdf · FOI
- Posatex® Otic Suspension · SPL
- UCM504539.pdf · FOI
- Mometavet® · SPL
No source yet.
- 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/689 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/688 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/687 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/489/Mometamax%E2%84%A2%20Otic%20Suspension · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16869 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17190/Mometamax%20Single%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
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:15 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- 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. (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 0061-0089-01 | 0061 | - | |
| 0061-0089-02 | 0061 | - | |
| 0061-0089-03 | 0061 | - | |
| 0061-1246-01 | 0061 | - | |
| 0061-1246-02 | 0061 | - | |
| 0061-1246-04 | 0061 | - | |
| 0061-1246-05 | 0061 | - | |
| 0061-5432-01 | 0061 | - | |
| 13985-701-07 | 13985 | - | |
| 13985-701-15 | 13985 | - | |
| 13985-701-21 | 13985 | - | |
| 13985-701-30 | 13985 | - | |
| 17030-001-10 | 17030 | - | |
| 17033-273-15 | 17033 | - | |
| 17033-273-21 | 17033 | - | |
| 17033-273-30 | 17033 | - | |
| 17033-273-75 | 17033 | - | |
| 51072-122-00 | 51072 | - | |
| 51072-122-01 | 51072 | - | |
| 51072-122-02 | 51072 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
FOI Summary oA 200-829 Approved December 22, 2025.pdf
• FOI summary • Official
• Jan. 5, 2026
FDA FOI summary for application 200829
-
ucm117265.pdf
• FOI summary • Official
• Dec. 3, 2025
FDA FOI summary for application 141177
-
ucm117268.pdf
• FOI summary • Official
• Dec. 3, 2025
FDA FOI summary for application 141177
-
ucm117269.pdf
• FOI summary • Official
• Dec. 3, 2025
FDA FOI summary for application 141177
-
FOI Summary oN 141-600 Approved April 29 2025_ef.pdf
• FOI summary • Official
• June 3, 2025
FDA FOI summary for application 141600
-
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
-
UCM256757.pdf
• FOI summary • Official
• March 23, 2020
FDA FOI summary for application 141266
-
UCM504539.pdf
• FOI summary • Official
• Aug. 16, 2016
FDA FOI summary for application 200536
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: 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 o… (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Lethargy (see also Central nervous system depression in … (Official, 2026-02-12)
- usage: For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aerugi… (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 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 |
|---|---|---|---|---|
|
Klentz™
RX
Florfenicol Mometasone furoate Terbinafine
Solution
• Otic
|
Aurora Pharmaceutical, Inc. | ANADA 200-829 | Approved | Jan 5, 2026 |
|
Mometamax™ Otic Suspension
RX
Clotrimazole Gentamicin Sulfate Mometasone Furoate Monohydrate
Liquid (Suspension)
• Topical
|
Intervet, Inc. | NADA 141-177 | Approved | Dec 3, 2025 |
|
Mometamax Single™
RX
Gentamicin Mometasone furoate posaconazole
Otic Suspension
• Otic
|
Intervet, Inc. | NADA 141-600 | Approved | Jun 3, 2025 |
|
SIMPLERA™
RX
Florfenicol Mometasone furoate Terbinafine
Solution
• Otic
|
Vetoquinol USA, Inc. | ANADA 200-719 | Approved | Oct 3, 2022 |
|
CLARO™
RX
Florfenicol Mometasone furoate Terbinafine
Solution
• Otic
|
Elanco US Inc. | NADA 141-440 | Approved | Aug 3, 2021 |
|
Posatex® Otic Suspension
RX
Mometasone Furoate Monohydrate Orbifloxacin posaconazole
Topical Suspension
• Otic
|
Intervet, Inc. | NADA 141-266 | Approved | Mar 23, 2020 |
|
Mometavet®
RX
Clotrimazole Gentamicin Sulfate Mometasone furoate
Suspension
• Otic
|
Med-Pharmex, Inc. | ANADA 200-536 | Approved | Aug 16, 2016 |
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
For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
Administer one dose (1 dropperette) per affected ear.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs.
Mometamax Single™ should be administered by veterinary personnel. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
Administer one dose (1 dropperette) per affected ear.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
CLARO™ is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
- Klentz™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm117269.pdf
Summary
New package size (7.5g bottle) -
FOI ucm117268.pdf
Summary
For the treament of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis) and certain bacteria ( Pseudomonas supp. including P. aeruginosa, coagulase positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci). -
FOI ucm117265.pdf
Summary
Mometamax™ Otic Suspension is indicated for the treatment of otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs.
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs.
- Mometamax Single™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
- SIMPLERA™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM465253.pdf
Summary
For the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Staphylococcus pseudintermedius).
- CLARO™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM256757.pdf
Summary
POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).
- Posatex® Otic Suspension (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM504539.pdf
Summary
For the treatment of otitis externa in dogs caused by susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Pseudomonas spp. [including P. aeruginosa], coagulase- positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).
- Mometavet® (ZIP)
FDA page: Open in Animal Drugs @ FDA
Usage
For the treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aeruginosa ], coagulase-positive staphylococci, Enterococcus faecalis , Proteus mirabilis , and beta-hemolytic streptococci). POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa , and Enterococcus faecalis ). CLARO™ is indicated 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
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
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 8 and Cat 8 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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, Unknown • Drug: MSK, Suspension • Reactions: Twitching, Neurological signs NOS • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-046411
- Serious AE: Yes
- Treated For AE: No
- Sex: Unknown
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Form: Suspension
Dog, Retriever - Labrador, Male, 14 year, 27.669 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 8 drops per animal, Frequency: 1 per day • Reactions: Loss of hearing, Drug administration duration too long • Outcome: Recovered with Sequela
- Report ID: USA-USFDACVM-2025-US-046917
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 14.00 Year
- Weight: 27.669 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Auricular (Otic)
- Form: Suspension
- Dose: 8 drops per animal
- Frequency: 1 per day
Cat, Norwegian Forest, Male, 10 month, 5 kilogram • Drug: MSK, Unknown • Reactions: No sign, Product compounding error
- Report ID: USA-USFDACVM-2025-US-025803
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 10.00 Month
- Weight: 5.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Dog, Terrier - Yorkshire, Female, 14 year • Drug: MSK, Suspension • Reactions: Loss of hearing, Medication error NOS, Tympanic rupture • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-017514
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 14.00 Year
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Form: Suspension
Dog, Male, 12 year, 10.9 kilogram • Drug: MSK, Suspension • Reactions: Loss of hearing • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-010498
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 12.00 Year
- Weight: 10.900 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Form: Suspension
Dog, Shepherd Dog - Australian, Male, 11 year, 24.9 kilogram • Drug: MSK, Suspension • Reactions: Loss of hearing, Uncomfortable • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-014406
- Serious AE: No
- Treated For AE: Yes
- Sex: Male
- Age: 11.00 Year
- Weight: 24.900 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Form: Suspension
Cat, British cat, Female, 3 month, 1.5 kilogram • Drug: MSK, Suspension • Reactions: Cough, Nasal discharge, Upper respiratory sounds • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2024-US-077320
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 3.00 Month
- Weight: 1.500 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Form: Suspension
Cat, Female, 7 month, 2.84 kilogram • Drug: MSK, Suspension • Reactions: Lack of efficacy - NOS, Diarrhea • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2024-US-069150
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 7.00 Month
- Weight: 2.840 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Form: Suspension
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.
Share Your Thoughts
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.