Label: SYNOVEX ONE- trenbolone acetate and estradiol benzoate implant

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated October 26, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    SYNOVEX® ONE FEEDLOT
    (trenbolone acetate and estradiol benzoate extended-release implants)
    200 mg trenbolone acetate and 28 mg estradiol benzoate per implant

    SUBCUTANEOUS IMPLANTS FOR STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER

  • DESCRIPTION

    SYNOVEX ONE Feedlot (trenbolone acetate and estradiol benzoate extended-release implants) is a growth promoting implant containing 200 mg of trenbolone acetate and 28 mg of estradiol benzoate with a porous polymer film coating that extends the pay-out period of the final formulation up to 200 days. Each implant consists of 8 pellets. Ten implants are provided in each cartridge.

  • NOTE

    Studies have demonstrated that the administration of SYNOVEX ONE Feedlot can result in decreased marbling scores when compared to non-implanted steers and heifers.

  • DOSAGE

    One implant (8 pellets), containing 200 mg of trenbolone acetate and 28 mg of estradiol benzoate, is administered to each steer or heifer by subcutaneous implantation in the middle one-third of the ear.

    The ten-dose cartridge of SYNOVEX ONE Feedlot is designed to be used exclusively with a Synovex Applicator.

  • WITHDRAWAL PERIOD

    No withdrawal period is required when used according to labeling.

    A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

    Implant pellets in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food.

  • WARNINGS

    NOT FOR USE IN HUMANS.

    FOR ANIMAL USE ONLY.

  • ANIMAL SAFETY WARNING

    Bulling, vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in eifers administered SYNOVEX ONE Feedlot implants.

  • DIRECTIONS

    Implant complete contents of one cartridge cell per steer or heifer. Approved implantation technique is fully described in the fold-out carton section.

    NOTE: Never sacrifice careful, clean technique for speed of implantation.

  • STORAGE

    Store unopened product at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat and humidity. Use product before the expiration date on the label.

    Once the pouch is opened, unused product may be stored in the end-folded pouch (away from light) for up to six months under refrigerated conditions 2°-8°C (36°-47°F) or at room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F) for up to one month.

  • DISPOSAL

    SYNOVEX ONE Feedlot waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

  • INDICATIONS FOR USE

    For increased rate of weight gain and improved feed efficiency for up to 200 days in steers and heifers fed in confinement for slaughter.

    Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

    Not for use in dairy or beef replacement heifers.

  • NET CONTENTS

    One pouch contains ten 10-dose cartridges (100 implants).

  • SPL UNCLASSIFIED SECTION

    Manufactured By A Non-Sterilizing Process

    Keep this and all drugs out of the reach of children.

    Restricted Drug (California)—Use Only As Directed.

  • IMPORTANT

    Read ALL sides of carton

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under NADA 141-348

    zoetis

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    6213A
    40030751

  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

    Synovex One Feedlot
  • INGREDIENTS AND APPEARANCE
    SYNOVEX ONE 
    trenbolone acetate and estradiol benzoate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-2010
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    trenbolone acetate (UNII: RUD5Y4SV0S) (trenbolone - UNII:P53R4420TR) trenbolone acetate200 mg
    estradiol benzoate (UNII: 1S4CJB5ZGN) (estradiol - UNII:4TI98Z838E) estradiol benzoate28 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-2010-110 in 1 CARTON
    110 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14134806/10/2014
    Labeler - Zoetis Inc. (828851555)