SYNOVEX C- progesterone and estradiol benzoate implant 
Zoetis Inc.

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Synovex® C

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.

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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.

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

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Revised: May 2023

40039892

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

40039892

carton label
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)

Revised: 7/2023
Document Id: a9ac35b7-0c60-4a43-a608-d26d2761e036
Set id: 23d4e626-9ba0-4e5a-8a52-616546cdc2da
Version: 6
Effective Time: 20230706
 
Zoetis Inc.