Synovex Primer

Manufacturer
Zoetis Inc.
Effective date
2025-02-21
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:44:21

Label at a glance#

ProductSynovex Primer
Active ingredientTRENBOLONE ACETATE, ESTRADIOL BENZOATE
Label structure14 sections

Dosage and administration

Administer one SYNOVEX® PRIMER™ implant (two pellets), containing 50 mg of trenbolone acetate and 7 mg of estradiol benzoate, to each steer or heifer by subcutaneous implantation in the middle-third of the ear. Use only a SYNOVEX applicator. Approved implantation technique is fully described in the fold-out carton section. Never sacrifice careful, clean technique for speed of implantation.

Storage and handling

Store unopened product at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat and humidity. Use product before the expiration date on the label. Once the pouch is opened, unused product may be stored in the end-folded pouch (away from light) for up to six months under refrigerated conditions 2°-8°C (36°-47°F) or at room temperature 20°-25°C (68°-77°F) w...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SYNOVEX Primer®
(trenbolone acetate and estradiol benzoate implants)
50 mg trenbolone acetate and 7 mg of estradiol benzoate per implant

SUBCUTANEOUS IMPLANTS FOR GROWING BEEF STEERS AND HEIFERS ON PASTURE AND IN A DRY LOT

DESCRIPTION SECTION

SYNOVEX® PRIMER™ (trenbolone acetate and estradiol benzoate implants) is a growth promoting implant containing 50 mg of trenbolone acetate and 7 mg of estradiol benzoate per implant. Each implant consists of 2 pellets. Ten implants are provided in each cartridge.

WITHDRAWAL PERIODS AND RESIDUE WARNINGS

WARNINGS SECTION

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

USER SAFETY WARNINGS SECTION

Not for use in humans. Keep out of reach of children.

ANIMAL SAFETY WARNINGS

WARNINGS SECTION

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® PRIMER™ implants.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Administer one SYNOVEX® PRIMER™ implant (two pellets), containing 50 mg of trenbolone acetate and 7 mg of estradiol benzoate, to each steer or heifer by subcutaneous implantation in the middle-third of the ear.

Use only a SYNOVEX applicator. Approved implantation technique is fully described in the fold-out carton section. Never sacrifice careful, clean technique for speed of implantation.

STORAGE

STORAGE AND HANDLING SECTION

Store unopened product at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat and humidity. Use product before the expiration date on the label.

Once the pouch is opened, unused product may be stored in the end-folded pouch (away from light) for up to six months under refrigerated conditions 2°-8°C (36°-47°F) or at room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F) for up to one month.

DISPOSAL

ENVIRONMENTAL WARNING SECTION

SYNOVEX® PRIMER™ waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.

INDICATIONS FOR USE

VETERINARY INDICATIONS SECTION

• For increased rate of weight gain in growing beef steers and heifers on pasture (stocker, feeder, and slaughter).
• For increased rate of weight gain in growing beef steers and heifers in a dry lot.1
• This implant is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant
in growing beef steers and heifers on pasture or in a dry lot 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 established.

Do not use in animals intended for subsequent breeding, or in dairy cows.

1CVM Appendix III of GFI 191, August 27, 2020, www.fda.gov/animal-veterinary/new-animal-drugapplications
classes-major-food-producing-animals-newanimal-drug-applications#beef

QUESTIONS/COMMENTS?

SPL UNCLASSIFIED SECTION

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 www.fda.gov/reportanimalae.

SPL UNCLASSIFIED SECTION

Manufactured By A Non-Sterilizing Process

Restricted Drug (California)—Use Only As Directed.

IMPORTANT

SPL UNCLASSIFIED SECTION

Read ALL sides of carton

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 141-043

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

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

40044978

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

applicators
applicators
steps
steps

40049311

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2686069estradiol 3-benzoate 7 MG / trenbolone acetate 50 MG Drug ImplantPSN2
2686071SYNOVEX PRIMER 50 MG / 7 MG Drug ImplantPSN2
2686071estradiol 3-benzoate 7 MG / trenbolone acetate 50 MG Drug Implant [Synovex]SBD2
2686069estradiol 3-benzoate 7 MG / trenbolone acetate 50 MG Drug ImplantSCD2
2686071Synovex Primer (estradiol benzoate 7 MG / trenbolone acetate 50 MG) Drug ImplantSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
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3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
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5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54771-6870-1Synovex Primer1 in 1 BOXIMPLANT12
54771-6870-1Synovex Primer10 in 1 POUCHIMPLANT102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-6870SYNOVEX PRIMER (TRENBOLONE ACETATE AND ESTRADIOL BENZOATE) IMPLANT [ZOETIS INC.]22 package rows20250223_8893799d-d617-43dc-bcd2-5604deadb694.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54771-687054771-6870-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRENBOLONE ACETATERUD5Y4SV0SACTIB
ESTRADIOL BENZOATE1S4CJB5ZGNACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.