522.1660b Oxytetracycline solution, 300 milligram/milliliter.

Special considerations: When labeled for the treatment of anaplasmosis or anthrax, labeling shall also bear the following: ``Federal law restricts this drug to use by or on the order of a licensed veterinarian.''

Conditions of use:

Beef cattle, nonlactating dairy cattle, and calves including prereruminating (veal) calves

Amount: 3 to 5 milligrams per pound of bodyweight per day.

Indications: For treatment of pneumonia and shipping fever complex associated with Pasteurella species and Histophilus species, foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, wound infections and acute metritis caused by Staphylococcus species and Streptococcus species

Limitations: Administer intramuscularly, subcutaneously, or intravenously. Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration in cattle may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Not for use in lactating dairy animals.

Amount: 5 milligrams per pound of bodyweight per day.

Indications: For treatment of severe foot-rot, and advanced cases of other indicated diseases.

Limitations: Administer intramuscularly or subcutaneously. Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration in cattle may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Not for use in lactating dairy animals.

Amount: 9 milligrams per pound of bodyweight as a single dose.

Indications: Where retreatment of calves and yearlings for bacterial pneumonia is impractical or for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis.

Limitations: Administer intramuscularly or subcutaneously. Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration in cattle may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Not for use in lactating dairy animals. Amount: 9 to 13.6 milligrams per pound of bodyweight as a single dose.

Indications: Where retreatment of calves and yearlings for bacterial pneumonia is impractical or for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis.

Limitations: Administer intramuscularly or subcutaneously. Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration in cattle may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Not for use in lactating dairy animals.

Amount: 13.6 milligrams per pound of bodyweight as a single dose.

Indications: For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica.

Limitations: Administer intramuscularly or subcutaneously. Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration in cattle may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Not for use in lactating dairy animals.

Swine

Amount: 3 to 5 milligrams per pound of bodyweight per day; 9 milligrams per pound of bodyweight as a single dosage where retreatment for pneumonia is impractical.

Indications: For treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona.

Limitations: Administer intramuscularly. Do not inject more than 5 mL per site in adult swine. Discontinue treatment at least 28 days prior to slaughter.

Sows:

Amount: 3 milligrams per pound of body weight.

Indications: As an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by E. coli.

Limitations: Administer once approximately 8 hours before farrowing or immediately after completion of farrowing.

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.