Label: SYNOVEX H- testosterone propionate and estradiol benzoate implant
- NDC Code(s): 54771-3901-1
- Packager: Zoetis Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated June 23, 2021
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SPL UNCLASSIFIED SECTION
200 mg testosterone propionate and 20 mg estradiol benzoate per implant
For increased rate of weight gain and improved feed efficiency
This product was manufactured by a non-sterilizing process.
Important: Read ALL sides of carton
For Heifers Only
Do Not Use In Veal Calves
Not For Use In Humans
For Animal Use Only
For subcutaneous ear implantation only.
Approved by FDA under NADA 011-427
Synovex H (testosterone propionate and estradiol benzoate implants) is recommended for use in heifers weighing 400 lbs or more.
When properly administered, Synovex H implants increase rate of weight gain and improve feed efficiency. Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.
Store at controlled room temperature 20° to 25°C (68° to 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.
Indications for Use
For Heifers Only Not For Use In Humans
Do Not Use In Veal Calves For Animal Use Only
Synovex H Heifer Implants contain two pure steroid hormones, testosterone propionate and estradiol benzoate. This formulation provides a complementary amount of each hormone for maximal growth stimulation. Study the enclosed instructions carefully and use this product only as illustrated.
Not for use in humans. For animal use only. Not for dairy or beef replacement heifers. Implant pellets in the ear only. Any other location is in violation of federal law. Do not attempt salvage of implanted site for human or animal food.
A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 Cartridge Implant Pouch
INGREDIENTS AND APPEARANCE
testosterone propionate and estradiol benzoate implant
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:54771-3901 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TESTOSTERONE PROPIONATE (UNII: WI93Z9138A) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE PROPIONATE 200 mg ESTRADIOL BENZOATE (UNII: 1S4CJB5ZGN) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL BENZOATE 20 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-3901-1 1 in 1 BOX 1 10 in 1 POUCH 1 10 in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA011427 11/07/2014 Labeler - Zoetis Inc. (828851555)