Label: SYNOVEX H- testosterone propionate and estradiol benzoate implant

  • 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® H

    (testosterone propionate and estradiol benzoate implants)
    200 mg testosterone propionate and 20 mg estradiol benzoate per implant

    SUBCUTANEOUS IMPLANTS FOR GROWING BEEF HEIFERS FED 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 # 011-427

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

    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 2 months of age, dairy calves, and veal calves. 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® H implants.

  • INDICATIONS FOR USE

    · For increased rate of weight gain and improved feed efficiency in growing beef heifers fed in confinement for slaughter.
    · Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant in growing beef heifers fed in confinement for slaughter as safety and effectiveness have not been evaluated.

    Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated.
    Do not use in animals intended for subsequent breeding, or in dairy cows.

  • Dosage

    Implant complete contents of one cartridge cell per heifer. Approved implantation technique is fully described in the package insert.

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

    Instructions graphic part 1
    Instructions graphic part 2
    Instructions graphic part 3
  • DIRECTIONS

    Implant complete contents of one cartridge cell per heifer. Approved implantation technique is fully described in the package insert.

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

  • 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.

  • HOW SUPPLIED

    100 Dose

  • 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

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Revised: May 2023
    40039999

  • PRINCIPAL DISPLAY PANEL - Carton of 10 cartridges

    40039999

    carton label
  • INGREDIENTS AND APPEARANCE
    SYNOVEX H 
    testosterone propionate and estradiol benzoate implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-3901
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TESTOSTERONE PROPIONATE (UNII: WI93Z9138A) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE PROPIONATE200 mg
    ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE20 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-3901-11 in 1 BOX
    110 in 1 POUCH
    110 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA01142711/07/2014
    Labeler - Zoetis Inc. (828851555)