SYNOVEX C (PROGESTERONE AND ESTRADIOL BENZOATE) IMPLANT [ZOETIS INC.]

SYNOVEX C (PROGESTERONE AND ESTRADIOL BENZOATE) IMPLANT [ZOETIS INC.]
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NDC 54771-3903-1, 54771-3903-2
Set ID 23d4e626-9ba0-4e5a-8a52-616546cdc2da
Category OTC ANIMAL DRUG LABEL
Packager Zoetis Inc.
Generic Name
Product Class
Product Number
Application Number NADA009576
  • SPL UNCLASSIFIED SECTION

    100 mg progesterone and 10 mg estradiol benzoate per implant

    CALF IMPLANTS. For increased rate of weight gain. For subcutaneous ear implantation only.

    Approved by FDA under NADA # 009-576

  • Description

    Synovex C Calf Implants contain two pure steroid hormones, progesterone and estradiol benzoate. This formulation provides a complementary amount of each hormone for maximal growth stimulation.

  • Indications

    Calf implants for increased rate of weight gain. Synovex C is recommended for use in suckling beef calves up to 400 lbs of body weight. Synovex C is also recommended for improvement in rate of weight gain in steers weighing greater than 400 pounds and fed in confinement for slaughter when used as part of a re-implant program in which an initial Synovex C implant is followed at approximately 70 days by Synovex S. . Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

  • Dosage & Administration

    Implant complete contents of one cartridge cell per calf at each implanting. 100 mg progesterone and 10 mg estradiol benzoate per implant

  • Food Safety Warning

    A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

    Implant pellets in the ear only. Any other location is in violation of federal law.

  • Warnings

    Not for use in humans. For animal use only.

  • SPL UNCLASSIFIED SECTION

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

  • PRECAUTIONS

    CAUTION: Bulling, rectal and vaginal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in calves administered with Synovex C implants.

  • Dosage and Administration

    DOSAGE: One implant (four pellets), containing 100 mg of progesterone and 10 mg of estradiol benzoate, is administered to each calf by subcutaneous implantation in the middle one-third of the ear.

    The twenty-dose cartridge of Synovex C is designed to be used exclusively with a Synovex applicator.

    Implant complete contents of one cartridge cell per calf at each implanting. Approved implantation technique is fully described in the package insert.

  • Storage and Handling

    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.

  • Environmental Warning

    DISPOSAL: SYNOVEX C waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

  • SPL UNCLASSIFIED SECTION

    This product was manufactured by a non-sterilizing process.
    Restricted Drug (California) — Use Only as Directed

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    NET CONTENTS: 10 CARTRIDGES (100 DOSES)
    Each Cartridge Contains 10 Rows of 4 Pellets.

  • PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

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

    CALF IMPLANTS

    For increased rate of weight gain

    This product was manufactured by
    a non-sterilizing process.

    TAKE TIME
    OBSERVE LABEL
    DIRECTIONS

    Important: Read ALL sides of carton
    Do Not Use In Veal Calves
    Not For Use In Humans
    For Animal Use Only

    For subcutaneous ear implantation only.

    Approved by FDA under NADA # 009-576

    zoetis

    NET CONTENTS: 10 CARTRIDGES (100 DOSES)
    Each Cartridge Contains 10 Rows of 4 Pellets.

    Synovex C extended content label (2)

     

    Synovex C extended content label (1)

  • 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)

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