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Roxee Meds Catalog

Amitraz

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Liquid Zoetis Inc. Official label facts Owner quick guide first

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Data freshness

Storefront facts
Catalog refreshed
May 5, 2026, 10:00 a.m.

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

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

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

Safety reports
No safety reports linked
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openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 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.

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

Updated: February 12, 2026, 10:44 PM UTC

Sources:
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Amitraz

Amitraz

Drug type: Generic ingredient • Generic profile No FDA branded products linked

Both Liquid Rx required 100% storefront ready

Species: Both

Manufacturer: Zoetis Inc.

Medication Snapshot

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

Amitraz

For the treatment of generalized demodicosis (Demodex canis). Species commonly shown: Both, Dog, No Use Class Stated Or Implied.

Generic name
Amitraz
Brand names
Mitaban® Liquid Concentrate
Manufacturer
Zoetis Inc.
Species
Both, Dog, No Use Class Stated Or Implied
Dosage forms
Liquid
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Mitaban® Liquid Concentrate
Dosage forms
Liquid

Indications / Uses

For the treatment of generalized demodicosis (Demodex canis).

Warnings / Contraindications

Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Lethargy (see also Central nervous system depression in 'Neurological'), Pruritus, Vomiting, Drug administration error, Alopecia general, Ataxia.

FAQ

Both, Dog, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Liquid

Related Conditions

Source Transparency

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Pet Owner Quick Guide

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

Used for:

For the treatment of generalized demodicosis (Demodex canis).

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:

  • Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied
  • Do not use for treatment of localized demodicosis or scabies
  • wobbly/unsteady walking (1 reports)
  • Syncope (1 reports)
  • Stomach upset (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?
Major cautions & emergency warning signs

Side effects to monitor:

  • Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied
  • Do not use for treatment of localized demodicosis or scabies
  • wobbly/unsteady walking
  • Syncope
  • Stomach upset

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Syncope (1 reports)
  • Stomach upset (1 reports)

Emergency warning signs:

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

Quick Facts

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

Species: Both
Manufacturer: Zoetis Inc.
Form: Liquid
Identifiers:
NADA: 120299
Source metadata:

Warnings / Contraindications

Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

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

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

Tracked signals
27
Reported cases
22
Serious reports
13
Species represented
1
Grouped by Body System
Digestive (2) · Loss of appetite, Vomiting Skin & allergy (2) · Itching, Alopecia general Neurologic (3) · Unsteady walking (ataxia), Tiredness (lethargy), Lethargy (see also Central nervous system depression in 'Neurological') Behavior (2) · Biting -aggression, Behavioral disorder (unspecified) Effectiveness (3) · Lack of efficacy (endoparasite) - NOS, Lack of efficacy (ectoparasite) - tick NOS, Lack of efficacy (ectoparasite) - flea Other (15) · Weight gain, Syncope, Stomach upset
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Effectiveness 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (27)

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

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

1

FOI

0
No FOI links yet.

Mitaban® Liquid Concentrate

SPL · SPL

FDA Structured Product Label

Mitaban® Liquid Concentrate

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

Sponsor
Zoetis Inc.
NADA
120-299
Status
RX
Form
Liquid
Route
Topical
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
Amitraz liquid contains 19.9 percent amitraz in an organic solvent.

Dogs

Indication
For the treatment of generalized demodicosis (Demodex canis).
Dosage
One 10.6 milliliter bottle per 2 gallons of warm water (250 parts per million) for each treatment, for a total of 3 to 6 treatments, 14 days apart.
Limitations
Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 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.
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Catalog species: Both FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Liquid Topical
Applications: NADA 120-299
Documents: • SPL: 1 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 0 Cat 0 View
Case summaries: 0
openFDA reports are unverified and do not prove causation.

Explore
Related conditions: Demodicosis
Linked using: Fda_Label (0.95)

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.

Owner-facing counseling points
  • Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Syncope (1) Stomach upset (1) Polyneuritis (1) Lack of efficacy (ectoparasite) - tick NOS (1) Drug administration error (1) Dilated pupils (1) Death by euthanasia (1)

Identifiers & Packages

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

Identifiers
NADA: 120299

Data Sources & Change Log

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

Official 5 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lethargy (see also Central nervous system depression in 'Neurological'), Pruritus, Vomiting, Drug administration error, Alope… (Clinical, 2026-04-11)
  • contraindications: Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatm… (Official, 2026-04-11)
  • contraindications: Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatm… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Lethargy (see also Central nervous system depression in 'Neurological'), Pruritus, Vomiting, Drug administration error, Alope… (Official, 2026-02-12)
  • usage: For the treatment of generalized demodicosis (Demodex canis). (Official, 2026-04-11)
  • usage: For the treatment of generalized demodicosis (Demodex canis). (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • 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
Mitaban® Liquid Concentrate
RX
Amitraz
Liquid Topical
Zoetis Inc. NADA 120-299 Approved Jun 1, 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.

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Amitraz liquid contains 19.9 percent amitraz in an organic solvent.
Dogs
Indication
For the treatment of generalized demodicosis (Demodex canis).
Dosage
One 10.6 milliliter bottle per 2 gallons of warm water (250 parts per million) for each treatment, for a total of 3 to 6 treatments, 14 days apart.
Limitations
Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of generalized demodicosis (Demodex canis).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Continue treatment until no viable mites are found in skin scrapings at 2 successive treatments, or until 6 treatments have been applied. Do not use for treatment of localized demodicosis or scabies. 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) • Dog Vomiting • Dog

Showing top 5 for Digestive.

Skin & allergy
Itching • Dog Alopecia general • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Tiredness (1) • Dog Tiredness (lethargy) • Dog

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Dog Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Effectiveness
Lack of efficacy (endoparasite) - NOS (1) • Dog Lack of efficacy (ectoparasite) - tick NOS (1) • Dog Lack of efficacy (ectoparasite) - flea • Dog

Showing top 5 for Effectiveness.

Other
Weight gain (1) • Dog Syncope (1) • Dog Stomach upset (1) • Dog Polyneuritis (1) • Dog Palpable mass NOS (1) • Dog
Show more (10)
Ocular discharge (1) • Dog Eyelid lump (1) • Dog Drug dose administration interval too short (1) • Dog Drug administration error (1) • Dog Dilated pupils (1) • Dog Death by euthanasia (1) • Dog Cognitive disorder NOS (1) • Dog Blindness (1) • Dog Anterior uveitis (1) • Dog Adipsia (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.

No case-level openFDA reports are linked for this medication yet.

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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