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NADA Number: 008-622

Proprietary Name Terramycin® Soluble Powder
Terramycin® Animal Formula
Sponsor Zoetis Inc.
Sponsor Address 333 Portage St.
Kalamazoo, MI    49007
Ingredients Oxytetracycline Hydrochloride
Species (Class) BEES (Honey bees)
CATTLE (Cattle, dairy, females under 20 months of age)
CATTLE (Cattle, beef)
CATTLE (Cattle, calves, excluding veal calves)
CHICKENS (Chicken, not laying eggs for human consumption)
FISH (Fish, finfish, fry and fingerlings)
SHEEP (DOMESTIC) (Sheep, no use class stated or implied)
SWINE (Swine, breeding swine)
SWINE (Swine, no use class stated or implied)
TURKEYS (Turkey, not laying eggs for human consumption)
TURKEYS (Turkey, growing)
Routes of Administration Per Os
Dosage Form Powder
Syrup
Liquid (solution)
Dispensing Status OTC
Withdrawal Time Cattle: 5 days before slaughter. A withdrawal time for pre-ruminating veal calves has not been established. Sheep: 5 days before slaughter. Swine: zero days before slaughter. Turkey: 5 days before slaughter. Honey bees: at least 6 weeks prior to main honey flow.
Dosage Amount,
Indications
& Limitations

520.1660d Oxytetracycline hydrochloride soluble powder.

Specifications: Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 ounce; jars: 2.25 pounds; and pails: 4.5 pounds).

Conditions of use:

Chickens

Amount: 200 to 400 milligrams per gallon of drinking water.

Indications: Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline.

Limitations: Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption.

Amount: 400 to 800 milligrams per gallon of drinking water.

Indications: Control of chronic respiratory disease (CRD) and air sac infections caused by Mycoplasma gallisepticum and E. coli susceptible to oxytetracycline; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline.

Limitations: Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption.

Turkeys

Amount: 200 - 400 milligrams per gallon of drinking water.

Indications: Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline.

Limitations: Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to human consumption.

Amount: 400 milligrams per gallon of drinking water.

Indications: Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline.

Limitations: Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption.

Turkeys (growing)

Amount: 25 milligrams per pound of body weight.

Indications: Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline.

Limitations: Prepare a fresh solution daily. Administer 7 to 14 days. Not to be used for more than 14 consecutive days. Use as sole source of drinking water. Do not use in birds producing eggs for human consumption.

Swine

Amount: 10 milligrams per pound of body weight

Indications: Control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline.

Limitations: Prepare a fresh solution daily. Administer up to 14 days. Do not use for more than 14 consecutive days. Use as a sole source of oxytetracycline.

Swine (breeding stock)

Amount: 10 milligrams per pound of body weight

Indications: Control and treatment of leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona susceptible to oxytetracycline.

Limitations: Prepare a fresh solution daily. Administer up to 14 days. Do not use for more than 14 consecutive days. Use as a sole source of oxytetracycline.

Cattle (calves, beef, and nonlactating dairy)

Amount: 10 milligrams per pound of body weight

Indications: Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline.

Limitations. Prepare a fresh solution daily. Administer up to 14 days. Do not use for more than 14 consecutive days. Use as sole source of oxytetracycline. Do not administer this product with milk or milk replacers. Administer 1 hour before or 2 hours after feeding milk or milk replacers. Withdraw 5 days prior to slaughter. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older.

Sheep

Amount: 10 milligrams per pound of body weight

Indications: Control and treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by P. multocida susceptible to oxytetracycline.

Limitations: Prepare a fresh solution daily. Administer up to 14 days. Do not use for more than 14 consecutive days. Use as a sole source of oxytetracycline.

Honey bees

Amount: 200 milligrams per colony, administered via either a 1:1 sugar syrup (equal parts of sugar and water weight to weight) or dusting with a powdered sugar mixture.

Indications: Control and treatment of American and European foul brood caused by Paenibacillus larvae susceptible to oxytetracycline.

Limitations: The drug is administered in 3 applications of sugar syrup or 3 dustings at 4- to 5- days intervals. The drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow.

NAS/NRC status: The conditions of use in this section are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in ? 514.111 of this chapter, but may require bioequivalency and safety information.

529.1660 Oxytetracycline.

Specifications: Each gram of powder contains 753 mg oxytetracycline hydrochloride.

Finfish fry and fingerlings

Amount. Immerse fish in a solution containing 200 to 700 mg oxytetracycline hydrochloride (buffered) per liter of water for 2 to 6 hours.

Indications: For skeletal marking of finfish fry and fingerlings.

Tolerances

Oxytetracycline Hydrochloride: 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.