Animal NDC 66104-7940-0 Terramycin 100 Mr
Oxytetracycline
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 66104-7940-0 |
| Proprietary Name | Terramycin 100 Mr What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| Non-Proprietary Name | Oxytetracycline What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| Labeler Name | Phibro Animal Health |
| Product Type | Vfd Type A Medicated Article Animal Drug |
| Usage Information |
|
| Active Ingredient(s) |
|
| Inactive Ingredient(s) |
|
| Marketing Category | NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| FDA Application Number | NADA095143 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
Terramycin 100 Mr Images
Terramycin 100 Mr Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
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.
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.
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.
Other
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)
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.