SYNOVEX

Manufacturer
Zoetis Inc.
Effective date
2026-06-12
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-16 05:10:01

Label at a glance#

ProductSynovex One
Active ingredientTRENBOLONE ACETATE, ESTRADIOL BENZOATE
Label structure13 sections

Dosage and administration

Each cartridge cell holds one implant (6 pellets), containing 150 mg trenbolone acetate and 21 mg of estradiol benzoate. Administer complete contents of one cartridge cell (one implant) to each steer or heifer by subcutaneous implantation in the middle one-third of the ear. The ten-dose cartridge of SYNOVEX ONE Grower is designed to be used exclusively with a Synovex® applicator. Approved implantation technique is...

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® ONE GROWER
(trenbolone acetate and estradiol benzoate extended-release implants)
150 mg trenbolone acetate and 21 mg estradiol benzoate per implant

SUBCUTANEOUS IMPLANTS FOR GROWING BEEF STEERS AND HEIFERS ON PASTURE, IN A DRY LOT AND FED IN CONFINEMENT FOR SLAUGHTER

Description

DESCRIPTION SECTION

SYNOVEX ONE Grower (trenbolone acetate and estradiol benzoate extended-release implants) is a growth promoting implant containing 150 mg of trenbolone acetate and 21 mg of estradiol benzoate per implant with a porous polymer film coating that extends the pay-out period of the final formulation up to 200 days. Each implant consists of six pellets. Ten implants are provided in each cartridge.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

One implant (six pellets), containing 150 mg of trenbolone acetate and 21 mg of estradiol benzoate, is administered to each steer or heifer by subcutaneous implantation in the middle one‑third of the ear.

The ten-dose cartridge of SYNOVEX ONE Grass is designed to be used exclusively with a Synovex Applicator.

WITHDRAWAL PERIODS AND RESIDUE WARNINGS

FOOD SAFETY WARNING 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

WARNINGS SECTION

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

ANIMAL SAFETY WARNING

SPL UNCLASSIFIED 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 ONE Grower implants.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Each cartridge cell holds one implant (6 pellets), containing 150 mg trenbolone acetate and 21 mg of estradiol benzoate.
Administer complete contents of one cartridge cell (one implant) to each steer or heifer by subcutaneous implantation in the middle one-third of the ear.
The ten-dose cartridge of SYNOVEX ONE Grower is designed to be used exclusively with 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 ONE Grower 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 for up to 200 days in growing beef steers and heifers on pasture (stocker, feeder, and slaughter).
• For increased rate of weight gain for up to 200 days in growing beef steers and heifers in a dry lot.
• For increased rate of weight gain for up to 200 days in growing beef steers and heifers fed in confinement for slaughter.
• Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant within each separate production phase:
- growing beef steers and heifers on pasture (stocker, feeder, and slaughter);
- growing beef steers and heifers in a dry lot;
- growing beef steers and heifers fed in confinement for slaughter.
• Safety and effectiveness following reimplantation 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.

NOTE: The administration of SYNOVEX ONE Grower may result in decreased marbling scores when compared to non-implanted steers and heifers.

NET CONTENTS

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Manufactured By A Non-Sterilizing Process

Restricted Drug (California)—
Use Only As Directed.

IMPORTANT:
Read ALL sides of carton

Approved by FDA under NADA # 141-348

zoetis

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

40034339

PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40055026

initial label view
initial label view

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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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
54771-201254771-2012-1

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22021-11-09full-release2026-06-01 02:41:07

Reported adverse events (FAERS/openFDA)#

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