SYNOVEX H- testosterone propionate and estradiol benzoate implant 
Zoetis Inc.

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Synovex H

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.

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Revised: May 2023
40039999

PRINCIPAL DISPLAY PANEL - Carton of 10 cartridges

40039999

carton label
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)

Revised: 7/2023
Document Id: 908cb1ce-d06b-4322-b16c-ba599cbfed10
Set id: 5cdef530-023e-4d34-8e97-77f143b0068f
Version: 7
Effective Time: 20230706
 
Zoetis Inc.