Oxytetracycline and polymyxin b

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This page reprints a manufacturer label. Everything below in quotation marks is copied from Terramycin®, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for Terramycin® by Zoetis Inc, a oxytetracycline and polymyxin b product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.

The label

Product: Terramycin®. Manufacturer: Zoetis Inc. FDA Structured Product Label set id 2623f078-1ce0-4ae3-98c5-657971bad554. Label effective 2025-09-24. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

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 which may occur secondary to other infectious diseases in the above species.

Dosage and Administration

Terramycin (Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment) should be administered topically to the eye 2–4 times daily. RECOMMENDED STORAGE Store at controlled room temperature between 20° to 25°C (68° to 77°F), with excursions between 15° to 30°C (59° to 86°F).

Warnings

Serious, life threatening, hypersensitivity (anaphylactic) reactions have been reported in some cats following application of antibiotic ophthalmic preparations. If your cat has swelling of the face, itching, appears weak, vomits, or has difficulty breathing within 4 hours of application you should discontinue treatment and contact your veterinarian immediately. Note : The use of oxytetracycline and other antibiotics may result in an overgrowth of resistant organisms such as Monilia, staphylococci, and other species of bacteria. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken.

Description

Terramycin (Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment) is an antibiotic, bright yellow in color, possessing potent antimicrobial activity. It is one of the most versatile of the broad-spectrum antibiotics, and is effective in the treatment of infections due to gram-positive and gram-negative bacteria, both aerobic and anaerobic, spirochetes, rickettsiae, and certain of the larger viruses. Polymyxin B sulfate is one of a group of related antibiotics derived from Bacillus polymyxa . The polymyxins are rapidly bactericidal, this action being exclusively against gram-negative bacteria. The broad-spectrum effectiveness of Terramycin against both gram-positive and gram-negative organisms is enhanced by the particular effectiveness of polymyxin B against infections associated with gram-negative organisms, especially those due to Pseudomonas aeruginosa , where polymyxin B is the antibiotic of choice. In addition, there is evidence to indicate that polymyxin B sulfate possesses some antifungal activity. The combined antibacterial effect of Terramycin plus polymyxin is at least additive and, in many instances, an actual synergistic action is obtained. Terramycin is an ointment of oxytetracycline hydrochloride and polymyxin B sulfate in a special petrolatum base. Each gram of ointment contains oxytetracycline HCl equivalent to 5 mg of oxytetracycline and 10,000 units of polymyxin B as the sulfate.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming oxytetracycline and polymyxin b as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 46 reports

Reactions most often coded in dogs, 46 reports
VeDDRA reaction termReports
Corneal ulcer9
Blepharospasm5
Eye pain5
Ocular discharge5
Vomiting5
Conjunctivitis4
Corneal disorder NOS4
Eye redness4
Death by euthanasia3
Keratoconjunctivitis sicca3
Lack of efficacy - NOS3
Weight loss3
Accidental exposure2
Blindness2
Cardiac enlargement2

Outcome as recorded by the reporter: Outcome Unknown 13; Ongoing 11; Recovered/Normal 4; Euthanized 3; Recovered with Sequela 1.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Cats: 196 reports

Reactions most often coded in cats, 196 reports
VeDDRA reaction termReports
Vomiting40
Eyelid oedema23
Conjunctivitis20
Anaphylaxis18
Diarrhoea16
Eye irritation15
Eye redness13
Lack of efficacy (bacteria) - NOS13
Lethargy (see also Central nervous system depression in 'Neurological')11
Ocular discharge11
Swelling around eye11
Swollen eye11
Squinting10
Death9
Lack of efficacy - NOS9

Outcome as recorded by the reporter: Ongoing 50; Recovered/Normal 33; Outcome Unknown 27; Died 10; Euthanized 2; Recovered with Sequela 1.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

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