Label: TERRAMYCIN 100 MR- oxytetracycline powder
- NDC Code(s): 66104-7940-0
- 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 December 7, 2021
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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. For use in dry milk replacers only.
CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential 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)
- FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.
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MIXING AND USE DIRECTIONS
FOR TYPE A MEDICATED ARTICLE QUANTITIES LESS THAN ONE POUND. MIX THE PROPER AMOUNT OF TYPE A MEDICATED ARTICLE WITH AT LEAST TEN POUNDS OF FEED INGREDIENTS TO MAKE A PREBLEND. ADD THE PREBLEND TO THE REMAINING FEED INGREDIENTS AND MIX THOROUGHLY.
INDICATIONS FOR USE
Use Level of Terramycin
LB OF Terramycin 100MR/TON
CALVES - MILK REPLACERS
Treatment of bacterial enteritis caused by Escherichia coli susceptible to oxytetracycline
10 mg/lb body weight daily Feed continuously for 7-14 days
201
1Calf weighing 100 lbs. consuming 1 lb. of dry milk replacer mixed with one gallon water.
HONEY BEES
Control of American Foulbrood caused by Paenibacillus larvae, and European Foulbrood caused by Melissococcus plutonius susceptible to oxytetracycline
200 mg/oz (Dusting)
200 mg/5 lb (Syrup)
800 mg/patty
(Extender Patty)
See Mixing, Preparation, and Feeding Directions below
Mixing and Use Directions for Honey Bees
To manufacture a Type C medicated feed containing 200 mg of oxytetracycline hydrochloride activity per oz (dusting Type C Medicated feed) mix 7 lb of Terramycin 100MR with 211 lb of powdered sugar (for a total of 218 lb). The resulting Type C medicated is fed as-is for dusting or may be used to prepare syrup and extender patty feeds.
Feeding Directions for Dusting:
Dusting: Apply 1 oz (200 mg oxytetracycline) of dusting Type C medicated feed per colony every 4 to 5 days for a total of 3 applications. Apply the dust on the outer parts or ends of the frames.
Caution: Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells.
Preparation and Feeding Directions for Syrup:
Preparation: First dissolve 1 oz (200 mg oxytetracycline) of the dusting Type C medicated feed in a small quantity of water, then mix into 5 lb of 1:1 sugar syrup (equal parts sugar and water. w/w).
Feeding: Feed 5 lb of syrup (200 mg oxytetracycline) per colony every 4 to 5 days for a total of 3 applications. Bulk feed the syrup using feeder pails, or division board feeders, or by filling the combs. Prepare fresh syrup for each application.
Preparation and Feeding Directions for Extender Patty:
Preparation: Make one patty by mixing 4 oz (800 mg oxytetracycline) of the dusting Type C medicated with 5.8 oz. (165 g) of vegetable shortening and 11.6 oz (330 g) of sugar.
Feeding: Place one patty per colony on the top bars of the brood nest frames in a single application.
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WARNING:
►Withdrawal Periods and Residue Warnings: Remove at least 6 weeks prior to main honey flow. Type C medicated feeds should be fed in the spring or fall and consumed by the bees before main honey begins to avoid contamination of production honey. Honey stored during medication periods in combs for surplus honey should be removed following final medication of the bee colony and must not be used for human food.
Warning: Do not use in a manner contrary to state apiary laws and regulations. Each state has specific regulations relative to disease control and medications. Contact the appropriate official or state departments of agriculture for specific inter- and intrastate laws and regulations.
NOT FOR HUMAN USE.
RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED.
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SPL UNCLASSIFIED SECTION
SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS,
USE DIRECTIONS AND WARNINGS.
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
Approved by FDA under NADA #095-143
7940000
101-9079-07
Net Weight 50 lb (22.7 kg)
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INGREDIENTS AND APPEARANCE
TERRAMYCIN 100 MR
oxytetracycline powderProduct Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:66104-7940 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S) OXYTETRACYCLINE HYDROCHLORIDE 100 g in 0.45 kg Inactive Ingredients Ingredient Name Strength DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66104-7940-0 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)