Animal NDC 58198-0369-2 Component Te-g With Tylan

Trenbolone Acetate, Estradiol, Tylosin Tartrate

Animal NDC Product Code 58198-0369-2

Field Name Field Value
Animal NDC Code 58198-0369-2
Proprietary Name Component Te-g With Tylan What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Trenbolone Acetate, Estradiol, Tylosin Tartrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Elanco Us Inc.
Product Type Otc Animal Drug
Active Ingredient(s)
  • Tylosin Tartrate
  • Trenbolone Acetate
  • Estradiol
Inactive Ingredient(s)
  • CHOLESTEROL (97C5T2UQ7J)
  • MAGNESIUM STEARATE (70097M6I30)
  • POVIDONE K30 (U725QWY32X)
  • ETHYLCELLULOSES (7Z8S9VYZ4B)
  • ISOPROPYL ALCOHOL (ND2M416302)
  • POLYETHYLENE GLYCOL 8000 (Q662QK8M3B)
  • CROSCARMELLOSE SODIUM (M28OL1HH48)
  • FD&C BLUE NO. 1 (H3R47K3TBD)
  • CHOLESTEROL (97C5T2UQ7J)
  • MAGNESIUM STEARATE (70097M6I30)
  • POVIDONE K30 (U725QWY32X)
  • ETHYLCELLULOSES (7Z8S9VYZ4B)
  • ISOPROPYL ALCOHOL (ND2M416302)
  • POLYETHYLENE GLYCOL 8000 (Q662QK8M3B)
  • CROSCARMELLOSE SODIUM (M28OL1HH48)
  • FD&C BLUE NO. 1 (H3R47K3TBD)
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200221 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Component Te-g With Tylan Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description:

Each cartridge belt holds 20 doses of Component TE-G with Tylan (trenbolone and estradiol and tylosin implant) Implants. Each dose of 3 pellets consists of 2 pellets containing a total of 40 mg of trenbolone acetate and 8 mg estradiol plus 1 pellet containing 29 mg tylosin tartrate as a local antibacterial. Component TE-G (trenbolone and estradiol implant) Implants are recommended for use in pasture cattle (slaughter, stocker, and feeder steers and heifers) for INCREASED RATE OF WEIGHT GAIN.

Indications For Use:

This product contains trenbolone acetate and estradiol in a slow-release delivery system which increases rate of weight gain in pasture cattle (slaughter, stocker, and feeder steers and heifers). Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

Dosage:

Administer 1 implant per animal according to the following instructions.

General Instructions:

Study the instructions which should be followed carefully at all times, avoiding short cuts. Skin infection can be avoided by properly preparing implant site and implanter. During fly season use fly repellent on implant site. One designated team member should always do the implanting. Cleanliness of hands and instruments is important at all times.

Warning:

Not to be used in animals intended for subsequent breeding, or in dairy animals. Implant one dose — 3 pellets (entire contents of one cartridge cell) — in the ear subcutaneously. Any other site of implantation is in violation of Federal Law. DO NOT attempt to salvage implantation site for animal feed or human 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.RESTRICTED DRUG (CALIFORNIA) — USE ONLY AS DIRECTED — FOR USE IN ANIMALS ONLY — NOT FOR HUMAN USE — KEEP OUT OF REACH OF CHILDRENIMPLANTING INSTRUCTIONS:

Loading The Implanter

Load the implanter following the instructions supplied with each implanter.

Restrain The Animal

Speed of implantation as well as safety of handlers is best achieved by restraining animal in a squeeze chute using head restraint. When implanting horned cattle, better control is obtained with additional use of nose tongs.

Prepare The Implant Site

Scrub the back side of the ear (implant site) with a piece of clean absorbent cotton which has been soaked with topical germicidal solution. Follow manufacturer's directions on germicide for correct strength and preparation of solution. Avoid getting disinfectant in animal's eyes.

Where To Implant

The full contents of one cartridge cell should be implanted beneath the skin on the back side of the middle one-third of the ear as illustrated in the drawing. The implant must not be closer to the head than the edge of the auricular cartilage ring farthest from the head. The location for insertion of the needle is a point toward the tip of the ear at least a needle length away from the intended deposition site. Avoid injuring the large arteries, veins and cartilage of the ear.

Insert The Needle

With one hand firmly grasp the ear. With the other hand insert needle point through the skin and ease forward on a lateral plane until the entire length of the needle is under the skin.

Implant The Pellets

After inserting the needle fully in the correct position, squeeze the trigger fully as the needle is withdrawn from the ear. This properly deposits the implant in the needle track. This procedure should prevent breakage or crushing of pellets if otherwise forced into contact with tough fibrous-tissue underlying the skin. The length and total contact area of the single dose are designed to permit absorption of the hormones after implantation to stimulate good weight gain. Broken or crushed pellets may interfere with rates of gain.

Clean The Needle

Clean the implanter needle with alcohol or a properly diluted germicidal solution prior to implanting the next animal.

Storage Conditions

Store in a refrigerator 2° to 8°C (36° to 46°F) and protect from sunlight.
Use before the expiration date printed on foil pouch. Discard open foil pouches.
ANADA 200-221, Approved by FDA
Manufactured by a non-sterilizing process.Component TE-G with Tylan is covered by U.S. Patent No. 5,874,098
Component, Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
Distributed by Elanco US Inc, Greenfield, IN 46140, USA
Tylosin: Product of the United Kingdom
To report adverse events, access medical information, or to obtain additional product information, call 1-800-428-4441

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.