Label: TERRAMYCIN 50- oxytetracycline powder
- NDC Code(s): 66104-7200-0
- Packager: Phibro Animal Health
- Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated July 20, 2023
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- Active Drug Ingredient:
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CAUTION:
CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.
CAUTION: For use in manufacturing medicated animal feeds only.
CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.
Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions–seek prompt medical treatment if such reactions are suspected.
- STORE AT OR BELOW 25°c (77°F), EXCURSIONS PERMITTED UP TO 40°C (104°F)SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONSUSE DIRECTIONS, AND WARNINGS
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FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.
Mixing and Use Directions
Thoroughly mix the amount of this Type A medicated article according to the directions below with at least an equal amount by weight of feed formula ingredients prior to blending into a complete feed.
Indications for Use
Oxytetracycline Amount
lb of
Terramycin 50/tonCHICKENS
Control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida
susceptible to oxytetracycline
100-200 g/ton
Feed continuously for 7-14 days
2-4
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasmagallisepticum and Escherichia coli susceptible to oxytetracycline
400 g/ton
Feed continuously for 7-14 days
8
Reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli susceptible to oxytetracycline
500 g/ton
Feed continuously for 5 days
10
WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Zero-day withdrawal period for lower use levels. Do not use in feed containing less than 0.55% dietary calcium. Use in such feeds may result in violative residues. Do not administer to chickens producing eggs for human consumption.
TURKEYS
Control of hexamitiasis caused by Hexamitameleagridis susceptible to oxytetracycline
100 g/ton
Feed continuously for 7-14 days
2
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline
200 g/ton
Feed continuously for 7-14 days
4
Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline
25 mg/lb of body weight daily
Feed continuously for 7-14 days
16.7¹
WARNING: At 200 g/ton use level or higher, withdraw 5 days before slaughter. Zero-day withdrawal period for lower use levels. Do not administer to turkeys producing eggs for human consumption.
SWINE
Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurellamultocida susceptible to oxytetracycline
10 mg/lb of body weight daily
Feed continuously for 7-14 days
102
For breeding swine for control and treatment of Leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline
10 mg/lb of body weight daily
Feed continuously for not more than 14 days
102
CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE
For growing cattle (over 400 lb) for the reduction of the incidence of liver abscesses
75 mg/head/day
Feed continuously
1.53
Prevention and treatment of the early stages of shipping fever complex. (Feed 3-5 days before and after arrival in feedlots.)
0.5-2.0 g/head/day
10-403
Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline
10 mg/lb of body weight daily
Feed continuously for 7-14 days
1004
SHEEP
Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline
10 mg/lb of body weight daily
Feed continuously for 7-14 days
245
WARNING: 5-day withdrawal before slaughter.
1If bird weighs 10 lb, consuming 0.6 lb of complete feed per day
2Pig consuming 4 lb of complete feed per 100 lb body weight per day
3Include in feed supplement based on consumption of 2 lb of supplement per head per day
4If animal weighs 500 lb, consuming 2 lb of supplement per head per day
5If lamb weighs 60 lb, consuming 1 lb of supplement per head per day
RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED
NOT FOR HUMAN USE
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SPL UNCLASSIFIED SECTION
Terramycin is a registered trademark of Pfizer, Inc.,
licensed to Phibro Animal Health Corporation, for Oxytetracycline
PHIBRO and PHIBRO logo design are trademarks owned by
Phibro Animal Health Corporation or its affiliates
Phibro Animal Health Corporation, Teaneck, NJ 07666
Net Weight 50 lb (22.7 kg)
Approved by FDA under NADA # 095-143
8842000
101-9009-10
- Princinipal Display Package
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INGREDIENTS AND APPEARANCE
TERRAMYCIN 50
oxytetracycline powderProduct Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:66104-7200 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S) OXYTETRACYCLINE HYDROCHLORIDE 50 g in 0.45 kg Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) CALCIUM CARBONATE (UNII: H0G9379FGK) RICE BRAN (UNII: R60QEP13IC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66104-7200-0 22.7 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA095143 03/31/2010 Labeler - Phibro Animal Health (006989008) Registrant - Phibro Animal Health (006989008)
