TERRAMYCIN 100 MR- oxytetracycline powder

Terramycin 100 MR by

Drug Labeling and Warnings

Terramycin 100 MR by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Drug Ingredient:

Oxytetracycline (from Oxytetracycline Dihydrate Base) Equivalent to

Oxytetracycline Hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . .100 grams per pound.

Inert ingredients:

Dextrose monohydrate.

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.

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 Streptococcus pluton susceptible to oxytetracycline	200 mg/colony	See Mixing Directions below
Warning: Remove at least 6 weeks prior to main honey flow.

Mixing and Use Directions for Honey Bees

Due to the high drug concentration of this product, an intermediate mixture must be prepared for use in bees. To prepare this intermediate mixture add 7 lb of Terramycin 100MR to 200 lb of powdered sugar and mix well. This mixture contains approximately 200 mg of oxytetracycline hydrochloride activity per oz.

Dusting Directions: Apply 1 oz (200 mg oxytetracycline) of this mixture per colony. Apply the dust on the outer parts or ends of the frames.

Syrup Directions: Use 1 oz (200 mg oxytetracycline) of this mixture per 5 lb jar containing 1:1 sugar syrup (equal parts sugar and water w/w) per colony. Dissolve in a small quantity of water before adding to syrup. Bulk feed the syrup using feeder pails or division board feeders or by filling the combs. Prepare fresh syrup for each application.

Administer in 3 applications of sugar syrup or 3 dustings at 4- to 5-day intervals. The drug should be fed in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey.

Extender Patty Directions: Use 4 oz (800 mg oxytetracycline) of this mixture mixed with 165 g of vegetable shortening (Crisco® or equivalent) and 330 g of sugar. The patties are placed on the top bars of the brood nest frames.

Contraindication: Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells.

WARNING:

This mixture should be fed in the spring or fall and consumed by the bees before main honey flow 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. Honey from bee colonies likely to be infected with foulbrood should not be used for preparation of medicated syrup supplements since it may be contaminated with spores of foulbrood and may result in spreading the disease. Remove at least 6 weeks before main honey flow. 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.

Crisco® is a trademark of Procter & Gamble, Cincinnati, OH 45202

NOT FOR HUMAN USE.

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED.

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

Net Weight 50 lb (22.7 kg)

NADA #95-143, APPROVED BY FDA

7940000

101-9079-06

Principal Display Panel

INGREDIENTS AND APPEARANCE

TERRAMYCIN 100 MR 
oxytetracycline powder

Product 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 (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)