SYNOVEX CHOICE (TRENBOLONE ACETATE AND ESTRADIOL BENZOATE) IMPLANT [ZOETIS INC.]

SYNOVEX CHOICE (TRENBOLONE ACETATE AND ESTRADIOL BENZOATE) IMPLANT [ZOETIS INC.]
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NDC 54771-3908-1
Set ID 721167af-d5a2-4a5e-afca-6b17465256ed
Category OTC ANIMAL DRUG LABEL
Packager Zoetis Inc.
Generic Name
Product Class
Product Number
Application Number NADA141043
  • SPL UNCLASSIFIED SECTION

    SUBCUTANEOUS IMPLANTS FOR STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER

    100 mg trenbolone acetate and 14 mg estradiol benzoate per implant

  • DESCRIPTION

    Synovex Choice (trenbolone acetate and estradiol benzoate implants) is a growth promoting implant containing 100 mg of trenbolone acetate and 14 mg of estradiol benzoate. Each implant consists of 4 pellets. Ten implants are provided in each cartridge.

  • INDICATIONS FOR USE

    For increased rate of weight gain in steers fed in confinement for slaughter, and for increased rate of weight gain and improved feed efficiency in 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.

    NOTE: Studies have demonstrated that the administration of Synovex Choice can result in decreased marbling scores when compared to non-implanted steers and heifers.

  • DOSAGE

    One implant (four pellets), containing 100 mg of trenbolone acetate and 14 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 Choice is designed to be used exclusively with a Synovex applicator.

  • WITHDRAWAL PERIODS

    No withdrawal period is required when used according to labeling.

    A withdrawal period has not been established for this product in preruminating 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.

  • 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 Choice waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

  • 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.

    See top of pouch for lot and expiration date.

    Approved by FDA under NADA 141-043

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    40030991
    6072E
    2017000

    NET CONTENTS: 10 CARTRIDGES
    Each Cartridge Contains 10 implants (100 implants total)

  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

    Synovex Choice Extended Content Label
  • INGREDIENTS AND APPEARANCE
    SYNOVEX CHOICE 
    trenbolone acetate and estradiol benzoate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-3908
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRENBOLONE ACETATE (UNII: RUD5Y4SV0S) (TRENBOLONE - UNII:P53R4420TR) TRENBOLONE ACETATE100 mg
    ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE14 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-3908-11 in 1 BOX
    110 in 1 POUCH
    110 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14104302/22/1996
    Labeler - Zoetis Inc. (828851555)

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