Label: REVALOR-IS- trenbolone acetate and estradiol implant

  • NDC Code(s): 57926-022-01
  • Packager: Merck Sharp & Dohme Corp.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 22, 2023

If you are a consumer or patient please visit this version.

  • VETERINARY INDICATIONS

    For Growing Beef Steers
    Fed In Confinement
    For Slaughter

  • DESCRIPTION

    Revalor®-IS is an implant containing 80 mg of trenbolone acetate and 16 mg estradiol. Each implant consists of 4 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.

  • 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.

    Figure 1
  • 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.

    Figure 2
  • METHOD OF USE

    1. Do not remove the cap of the cartridge containing the implants.
    2. 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.
    3. Gently push the cartridge into the slot until it clicks into place.
    4. The implanter is then ready for use.
    5. 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.
    6. 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.
    7. Withdraw the implanter. This will advance the cartridge one groove in the magazine and the next implant is now ready for use.
    8. 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.
    9. 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.
    Figure 3
  • 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).

  • 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

  • SPL UNCLASSIFIED SECTION

    Made in Austria by:
    Intervet GesmbH

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

    Copyright © 2023 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. 03/2023

    166104 R4

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

  • PRINCIPAL DISPLAY PANEL - 10 x 10 Cartridge Implant Box

    Revalor®-IS
    (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

    PRINCIPAL DISPLAY PANEL - 10 x 10 Cartridge Implant Box
  • INGREDIENTS AND APPEARANCE
    REVALOR-IS 
    trenbolone acetate and estradiol implant
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-022
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    trenbolone acetate (UNII: RUD5Y4SV0S) (trenbolone - UNII:P53R4420TR) trenbolone acetate80 mg
    estradiol (UNII: 4TI98Z838E) (estradiol - UNII:4TI98Z838E) estradiol16 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-022-0110 in 1 BOX
    110 in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14089711/27/1991
    Labeler - Merck Sharp & Dohme Corp. (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet GESMBH303380992MANUFACTURE