Animal NDC 57926-020-01 Revalor-s
Trenbolone Acetate And Estradiol

Animal Product Information

Field Name Field Value
Animal NDC Code 57926-020-01
Proprietary Name Revalor-s 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 And Estradiol 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 Merck Sharp & Dohme Corp.
Product Type Otc Animal Drug
Usage Information
    For increased rate of weight gain and improved feed efficiency in growing beef steers fed in confinement for slaughter.Not approved for repeated implantation (re-implantation) with this or any other cattle ear implant in growing beef steers fed in confinement for slaughter. Safety and effectiveness following re-implantation 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.
Active Ingredient(s)
  • Trenbolone Acetate
  • Estradiol
Marketing Category NADA - 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 NADA140897 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.

Revalor-s 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.

Table of Contents



Other



For Growing Beef Steers
Fed In Confinement
For Slaughter

QUESTIONS/COMMENTS? For a copy of the Safety Data Sheet or to report side effects, contact Merck Animal Health Technical Services at 1-800-211-3573. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Made in Austria by:
Intervet GesmbH

Distributed by:
Intervet Inc (d/b/a Merck Animal Health)
Madison, NJ 07940

Copyright© Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.

Restricted Drug (California) – use only as directed.

Approved by FDA under NADA # 140-897

Rev. 04/2023

Revalor is a registered trademark of Intervet Inc. or an affiliate.

167891 R4


Description



Revalor®-S is an implant containing 120 mg of trenbolone acetate and 24 mg estradiol. Each implant consists of 6 small yellow pellets. Ten implants are provided in a cartridge.

Manufactured by a non-sterilizing process.


Indications For Use



For increased rate of weight gain and improved feed efficiency in growing beef steers fed in confinement for slaughter.

Not approved for repeated implantation (re-implantation) with this or any other cattle ear implant in growing beef steers fed in confinement for slaughter. Safety and effectiveness following re-implantation 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



Studies have demonstrated that the administration of Revalor®-S can result in decreased marbling scores when compared to non-implanted steers.


Directions



The cartridge is designed to be used with a special implanting tool. The special implanting tool is available from Intervet Inc. Ten doses (implants) are in each cartridge. The implant is placed under the skin on the posterior aspect of the ear (see SITE OF IMPLANTATION and METHOD OF USE sections).

See Page 2, DIRECTIONS for more detailed implantation directions.

With the animal suitably restrained, the skin on the outer surface of the ear should be cleaned. The implant is then administered by the method shown in the diagram below.


Site Of Implantation



After appropriately restraining the animal to allow access to the ear, cleanse the skin at the implant needle puncture site. It is subcutaneous between the skin and cartilage on the back side of the ear and below the midline of the ear. The implant must not be placed closer to the head than the edge of the cartilage ring farthest from the head. The location of insertion of the needle is a point toward the tip of the ear and at least a needle length away from the intended deposition site. Care should be taken to avoid injuring the major blood vessels or cartilage of the ear.


Method Of Use



  • Do not remove the cap of the cartridge containing the implants.
  • Place the cartridge (D) with the capped end to the front into slot at the top of the implanter magazine marked (A) on the diagram.
  • Gently push the cartridge into the slot until it clicks into place.
  • The implanter is then ready for use.
  • Take the ear of the animal firmly with the free hand in the manner shown in Fig. 1. Then insert the needle into the subcutaneous tissue at the point indicated in Fig. 2.
  • After inserting the needle to its full extent, squeeze the trigger (E) gradually. Allow the pellets of the implant to be deposited in a single row.
  • Withdraw the implanter. This will advance the cartridge one groove in the magazine and the next implant is now ready for use.
  • When all the implants have been administered, the cartridge will discharge out the bottom of the magazine and may be replaced by a new one.
  • To change the needle, loosen the needle locking nut labeled (F) in Fig. 3 and replace the needle. Tighten the nut finger tight and the implanter is ready for use.

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 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.


Storage Conditions



Store unopened product at or below 25°C (77°F). Avoid excessive heat and humidity. Use product before the expiration date printed on the carton labeling and on the cartridge pouch. Opened cartridges may be stored in the foil pouch protected from light in the refrigerator (2-8°C/36-47°F) for up to 6 months.


How Supplied



Box of 10 cartridges, each containing 10 implants per cartridge (100 implants total).


Principal Display Panel - 10 X 10 Cartridge Implant Box



Revalor®-S
(trenbolone acetate and estradiol implants)

For Growing Beef Steers
Fed In Confinement
For Slaughter

Box of 10 x 10 Cartridge Implants
(100 Implants)

Manufactured by a non-sterilizing process

MERCK
Animal Health


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