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Roxee Meds Catalog

Polymyxin B

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

Both Catalog partial Not FDA-approved for animals H3 Medical 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.

Roxee has a partial storefront projection for this medication. Some primary facts still need verification.

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
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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 Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: May 2, 2026

Updated: May 2, 2026, 10:05 AM UTC

Sources:
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Polymyxin B

Polymyxin B

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

Both 83% storefront ready

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.

Polymyxin B

Terramycin® is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli , and A.aerogenes , such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions whichmay occur secondary to other infectious diseases in the above species. Terramycin Ophthalmic Ointment with Polymyxin B Sulfate is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli , and A. aerogenes , such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis. Species commonly shown: Both.

Generic name
Polymyxin B
Brand names
Polymyxin B Sulphate
Manufacturer
H3 Medical Inc
Species
Both
Completeness
83%
Validation
Incomplete
Brand names
Polymyxin B Sulphate

Indications / Uses

Terramycin® is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli , and A.aerogenes , such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions whichmay occur secondary to other infectious diseases in the above species. Terramycin Ophthalmic Ointment with Polymyxin B Sulfate is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli , and A. aerogenes , such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Loss of hearing, Deafness, Lack of efficacy - NOS, Impaired hearing, Hearing decreased, Behavioural disorder NOS.

FAQ

Both

Related Conditions

Blepharitis Conjunctivitis Corneal ulcer Pica Uveitis

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Pet Owner Quick Guide

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Used for:

Terramycin® is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli ,...

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 use in dogs only
  • Shake drug thoroughly and clean lesion before using
  • If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis
  • For otic use in dogs only
  • Do not administer orally
  • Do not use in dogs with known perforated tympanum
  • Do not use with drugs known to induce ototoxicity
  • wobbly/unsteady walking (1 reports)
  • Tremors (1 reports)
  • Mewing (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:

  • For use in dogs only
  • Shake drug thoroughly and clean lesion before using
  • If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis
  • For otic use in dogs only
  • Do not administer orally

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Tremors (1 reports)
  • Mewing (1 reports)

Emergency warning signs:

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

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

Species: Both
Manufacturer: H3 Medical Inc
Identifiers:
ANADA: 200553 NADA: 141298 NADA: 38801 NADA: 40123 NADA: 49725 NADA: 49726 NADA: 65015 NADA: 65016 NADA: 65114 NADA: 65119 NADA: 65476 NADA: 65485 NADA: 8763 NDC Package: 54771-1096-1 NDC Package: 58198-0813-1 NDC Package: 58198-0813-2 NDC Package: 63732-2043-4 NDC Product: 54771 NDC Product: 58198 NDC Product: 63732

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. 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 use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. 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
32
Reported cases
32
Serious reports
9
Species represented
2
Grouped by Body System
Digestive (1) · Loss of appetite Skin & allergy (2) · Itching, Alopecia NOS Neurologic (3) · Unsteady walking (ataxia), Tremors, Head tremor Behavior (2) · Head shake - behavioural disorder, Behavioral disorder (unspecified) Other (24) · Ulceration NOS, Third eyelid extrusion, Squinting
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Neurologic 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Neurologic 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Dog (22) Cat (10)

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

2

Polymyxin B Sulphate SPL

SPL · Structured Product Label

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

UCM457307.pdf

FOI · FOI summary

Open original

UCM202424.pdf

FOI · FOI summary

Open original
Source metadata:
Veterinary reference (advanced)

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

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Polymyxin B Sulphate
Manufacturer mapping: H3 Medical Inc
Catalog species: Both
NDC: Packages 63732-2043-4 • Products 63732
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Usage_Inferred (0.78), Usage_Inferred (0.78), Usage_Inferred (0.78)
Diagnosis Codes
ICD10_CM: H60.90 ICD10_CM: L20.9
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
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. 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) Tremors (1) Mewing (1) Loss of hearing (1) Hearing affected (1) Head tremor (1) Ear infection NOS (1) Ear discharge (1)

Identifiers & Packages

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

Identifiers
ANADA: 200553 NADA: 141298 NADA: 38801 NADA: 40123 NADA: 49725 NADA: 49726 NADA: 65015 NADA: 65016 NADA: 65114 NADA: 65119 NADA: 65476 NADA: 65485 NADA: 8763 NDC Package: 54771-1096-1 NDC Package: 58198-0813-1 NDC Package: 58198-0813-2 NDC Package: 63732-2043-4 NDC Product: 54771 NDC Product: 58198 NDC Product: 63732
Package NDC Product NDC Form / Route Status
54771-1096-1 54771 -
58198-0813-1 58198 -
58198-0813-2 58198 -
63732-2043-4 63732 -

Enriched Documents

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

  • Polymyxin B Sulphate SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • UCM457307.pdf • FOI summary • Official • Oct. 25, 2023
    FDA FOI summary for application 200553
  • UCM202424.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141298

Data Sources & Change Log

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

Official 18 Clinical 9 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using… (Clinical, 2026-05-02)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using… (Clinical, 2026-04-15)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using… (Clinical, 2026-04-11)
  • side_effects: Top reported reactions (openFDA): Loss of hearing, Deafness, Lack of efficacy - NOS, Impaired hearing, Hearing decreased, Behavioural disorder NOS. (Clinical, 2026-05-02)
  • side_effects: Top reported reactions (openFDA): Loss of hearing, Deafness, Lack of efficacy - NOS, Impaired hearing, Hearing decreased, Behavioural disorder NOS. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Loss of hearing, Deafness, Lack of efficacy - NOS, Impaired hearing, Hearing decreased, Behavioural disorder NOS. (Clinical, 2026-04-11)
  • usage: Terramycin® is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, inc… (Clinical, 2026-05-02)
  • usage: Terramycin® is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, inc… (Clinical, 2026-04-15)
  • usage: Terramycin® is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, inc… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using… (Official, 2026-04-30)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using… (Official, 2026-02-12)
  • manufacturer_name: H3 Medical Inc (Official, 2026-05-05)
  • manufacturer_name: H3 Medical Inc (Official, 2026-05-03)
  • manufacturer_name: H3 Medical Inc (Official, 2026-05-02)
  • manufacturer_name: H3 Medical Inc (Official, 2026-04-29)
  • manufacturer_name: H3 Medical Inc (Official, 2026-04-28)
  • manufacturer_name: H3 Medical Inc (Official, 2026-04-27)
  • manufacturer_name: H3 Medical Inc (Official, 2026-04-26)
  • manufacturer_name: H3 Medical Inc (Official, 2026-04-25)
  • manufacturer_name: H3 Medical Inc (Official, 2026-04-22)
Recent Revisions
  • side_effects updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • 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

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

Usage

Terramycin® is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli , and A.aerogenes , such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions whichmay occur secondary to other infectious diseases in the above species. Terramycin Ophthalmic Ointment with Polymyxin B Sulfate is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli , and A. aerogenes , such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. 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

Showing top 5 for Digestive.

Skin & allergy
Itching (1) • Cat Alopecia NOS (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Tremors (1) • Dog Head tremor (1) • Dog

Showing top 5 for Neurologic.

Behavior
Head shake - behavioural disorder (1) • Dog Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Other
Ulceration NOS (1) • Cat Third eyelid extrusion (1) • Cat Squinting (1) • Dog Platelet disorder NOS (1) • Dog Pinnae disorder (1) • Cat
Show more (19)
Other abnormal test result NOS (1) • Cat Neutropenia (1) • Dog Mewing (1) • Cat Medication error NOS (1) • Dog Loss of hearing (1) • Cat Leucopenia NOS (1) • Dog Hypoalbuminaemia (1) • Dog Hearing affected (1) • Dog Head shake - ear disorder (1) • Dog Falling (1) • Dog Eye irritation (1) • Dog Eosinopenia (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Ear infection NOS (1) • Dog Ear discharge (1) • Dog Decreased red blood cell count (1) • Dog Decreased haematocrit (1) • Dog Deafness (1) • Dog Crust (1) • Cat

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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