SYNOVEX S- progesterone and estradiol benzoate implant 
Zoetis Inc.

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Synovex® S

Synovex® S
(progesterone and estradiol benzoate implants)
200 mg progesterone and 20 mg estradiol benzoate per implant

SUBCUTANEOUS IMPLANTS FOR GROWING BEEF STEERS 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 # 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 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® S implants.

DIRECTIONS

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

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

instructions graphic 1
instructions graphic 2
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INDICATIONS FOR USE

• For increased rate of weight gain and improved feed efficiency in growing beef steers fed in confinement for slaughter.
• For increased rate of weight gain in growing beef steers fed in confinement for slaughter in a reimplantation program where SYNOVEX® C or SYNOVEX® S 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 in growing beef steers 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.

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.

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

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

Revised: May 2023
40039996

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

40039996

carton label
SYNOVEX  S
progesterone and estradiol benzoate implant
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-3902
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE200 mg
ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE20 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54771-3902-110 in 1 BOX
110 in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA00957611/07/2014
Labeler - Zoetis Inc. (828851555)

Revised: 7/2023
Document Id: 5d0c7fb9-e481-455a-bb96-71d723153446
Set id: 6d4c6678-278b-4242-b56d-286686d9875f
Version: 6
Effective Time: 20230706
 
Zoetis Inc.