Complete Up To Date Information about Forte Topical Ointment.
NADA Number: 065-119 | |
| Proprietary Name |
Forte Topical® Ointment |
|---|---|
| Sponsor |
Pharmacia & Upjohn Co. |
| Sponsor Address |
a Division of Pfizer, Inc. 235 East 42nd St. New York, NY 10017 USA |
| Ingredients |
Penicillin G Procaine Hydrocortisone Acetate Polymyxin B Sulfate Neomycin Sulfate |
| Species |
Cat, no use class stated or implied Dog, no use class stated or implied |
| Routes of Administration |
Topical |
| Dose Form |
Ointment |
| Drug Form |
Ointment |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1484h Neomycin, penicillin, polymyxin, hydrocortisone suspension. Specifications: Each milliliter of suspension contains 25 milligrams of neomycin sulfate equivalent to 17.5 milligrams of neomycin, 10,000 international units of penicillin G procaine, 5,000 international units of polymyxin B sulfate, 2 milligrams of hydrocortisone acetate, and 1.25 milligrams of hydrocortisone sodium succinate. Conditions of use: Dogs Amount: Rub a small amount into the involved area 1 to 3 times a day. After definite improvement, it may be applied once a day or every other day. Indications: Treatment of summer eczema, atopic dermatitis, interdigital eczema and otitis externa caused by bacteria susceptible to neomycin, penicillin, and polymyxin B. Limitations: 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 licenses veterinarian. The labeling shall state: This medication contains penicillin. Allergic reactions in human are known to occur from topical exposure to penicillin. |
| Tolerances |
Tolerances are established for residues of parent neomycin in uncooked edible tissues as follows: a. In cattle, swine, sheep, and goats: 7.2 parts per million in kidney (target tissue) and fat, 3.6 ppm in liver, and 1.2 ppm in muscle. b. In turkeys: 7.2 ppm in skin with adhering fat, 3.6 parts per million in liver, and 1.2 ppm in muscle. c. In milk: 0.15 part per million. A tolerance is established for negligible residues of hydrocortisone (as hydrocortisone sodium succinate or hydrocortisone acetate) in milk at 10 parts per billion. Tolerances are established for residues of penicillin and the salts of penicillin in food as follows: a. In cattle: 0.05 part per million (negligible residue) in the uncooked edible tissues b. In chickens, pheasants, quail, swine, and sheep: zero in the uncooked edible tissues c. In milk or any processed food in which milk has been used: zero d. In eggs: zero e. In turkeys: 0.01 part per million in the uncooked edible tissues |