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Proprietary Name	Terramycin® Ophthalmic Ointment with Polymyxin
NADA Number: 008-763
Sponsor	Pfizer, Inc.
Sponsor Address	235 East 42d St. New York, NY 10017 USA
Ingredients	Oxytetracycline Hydrochloride Polymyxin B Sulfate
Species	Cat, no use class stated or implied Horse, no use class stated or implied Dog, no use class stated or implied Cattle, no use class stated or implied Sheep, no use class stated or implied
Routes of Administration	Opthalmological
Dose Form	Ointment
Drug Form	Ointment
Dispensing Status	OTC
Dosage Amount, Indications & Limitations	524.1662b Oxytetracycline hydrochloride, polymyxin B sulfate ophthalmic ointment. Specifications: Each gram of the ointment contains oxytetracycline hydrochloride equivalent to 5 milligrams of oxytetracycline and 10,000 units of polymyxin B sulfate. Conditions of use: Dogs Amount: It is administered topically to the eye two to four times daily. Indications: The drug is used for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms. These infections include the following: Ocular infections due to streptococci, rickettsiae E. coli, and A. aerogenes (such as conjunctivitis, keratitis, pinkeye, corneal ulcer, and blepharitis in dogs); ocular infections due to secondary bacterial complications associated with distemper in dogs; and ocular infections due to bacterial inflammatory conditions which may occur secondary to other diseases in dogs. Limitations: Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken. Cats Amount: It is administered topically to the eye two to four times daily. Indications: The drug is used for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms. These infections include the following: Ocular infections due to streptococci, rickettsiae E. coli, and A. aerogenes (such as conjunctivitis, keratitis, pinkeye, corneal ulcer, and blepharitis in cats) and ocular infections due to bacterial inflammatory conditions which may occur secondary to other diseases in cats. Limitations: Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken. Cattle Amount: It is administered topically to the eye two to four times daily. Indications: The drug is used for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms. These infections include the following: Ocular infections due to streptococci, rickettsiae E. coli, and A. aerogenes (such as conjunctivitis, keratitis, pinkeye, corneal ulcer, and blepharitis in cattle) and ocular infections due to bacterial inflammatory conditions which may occur secondary to other diseases in cattle. Limitations: Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken. Sheep Amount: It is administered topically to the eye two to four times daily. Indications: The drug is used for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms. These infections include the following: Ocular infections due to streptococci, rickettsiae E. coli, and A. aerogenes (such as conjunctivitis, keratitis, pinkeye, corneal ulcer, and blepharitis in sheep) and ocular infections due to bacterial inflammatory conditions which may occur secondary to other diseases in sheep. Limitations: Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken. Horses Amount: It is administered topically to the eye two to four times daily. Indications: The drug is used for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms. These infections include the following: Ocular infections due to streptococci, rickettsiae E. coli, and A. aerogenes (such as conjunctivitis, keratitis, pinkeye, corneal ulcer, and blepharitis in horses) and ocular infections due to bacterial inflammatory conditions which may occur secondary to other diseases in horses. Limitations: Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken.
Tolerances	Beef cattle, dairy cattle, calves, swine, sheep, chickens, turkeys, finfish and lobster. Tolerances are established for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, in tissues and milk as follows: a. 2 parts per million (ppm) in muscle b. 6 ppm in liver c. 12 ppm in fat and kidney d. 0.3 ppm in milk.