Label: SYNOVEX C- progesterone and estradiol benzoate implant

  • NDC Code(s): 54771-3903-1, 54771-3903-2
  • Packager: Zoetis Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated July 6, 2023

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

  • SPL UNCLASSIFIED SECTION

    Synovex® C
    (progesterone and estradiol benzoate implants)
    100 mg progesterone and 10 mg estradiol benzoate per implant

    SUBCUTANEOUS IMPLANTS FOR BEEF CALVES AND GROWING BEEF STEERS IN CONFINEMENT FOR SLAUGHTER

    This product was manufactured by a non-sterilizing process.

    TAKE TIME OBSERVE LABEL DIRECTIONS

    Important: Read ALL sides of carton For subcutaneous ear implantation only.

    Approved by FDA under NADA # 009-576

    Restricted Drug (California) — Use Only as Directed

  • WITHDRAWAL PERIODS AND RESIDUE WARNINGS

    No withdrawal period is required when used according to labeling. Do not use in beef calves less than 45 days of age, dairy calves, and veal calves. Do not use in bull calves intended for reproduction. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Implant pellets subcutaneously in ear only. Any other location is a violation of Federal Law. Do not attempt salvage of implanted site for human or animal food.

  • USER SAFETY WARNINGS

    Not for use in humans. Keep out of reach of children.

  • ANIMAL SAFETY WARNINGS

    Bulling has occasionally been reported in implanted steers and heifers. Vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered SYNOVEX® C implants.

  • DIRECTIONS

    Implant complete contents of one cartridge cell to each steer or heifer at each implanting. Approved implantation technique is fully described in the package insert.

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

    instruction graphic 1
    instruction graphic 2
    instruction graphic 3
  • INDICATIONS FOR USE

    • For increased rate of weight gain in beef calves 45 days of age and older and weighing up to 400 lbs.
    • For increased rate of weight gain in growing beef steers fed in confinement for slaughter in a reimplantation program where SYNOVEX® C is the first implant and a SYNOVEX® S implant is administered approximately 70 days later.
    • Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant as safety and effectiveness have not been evaluated.

    Do not use in calves less than 45 days of age or veal calves because effectiveness and safety have not been evaluated.
    Do not use in animals intended for subsequent breeding, or in dairy cows.

  • Storage

    Store at controlled room temperature 20° - 25°C (68° - 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.

  • QUESTIONS/COMMENTS?

    For a copy of the Safety Data Sheet or to report side effects, contact Zoetis Inc. at 1-888-963-8471. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Revised: May 2023

    40039892

  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

    40039892

    carton label
  • INGREDIENTS AND APPEARANCE
    SYNOVEX C 
    progesterone and estradiol benzoate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-3903
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE100 mg
    ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE10 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-3903-12 in 1 CARTON
    2NDC:54771-3903-210 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA00957602/20/1956
    Labeler - Zoetis Inc. (828851555)