Revalor-H

Manufacturer
Merck Sharp & Dohme Corp. | Intervet GesmbH
Effective date
2025-09-29
Label type
OTC ANIMAL DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:45:02

Label at a glance#

ProductRevalor-H
Active ingredientTRENBOLONE ACETATE, ESTRADIOL
Label structure14 sections

Dosage and administration

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 th...

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For Growing Beef Heifers
Fed In Confinement
For Slaughter

DESCRIPTION:

DESCRIPTION SECTION

Revalor®-H is an implant containing 140 mg of trenbolone acetate and 14 mg estradiol. Each implant consists of 7 small yellow pellets. Ten implants are provided in a cartridge.

Manufactured by a non-sterilizing process.

INDICATIONS FOR USE:

INDICATIONS & USAGE SECTION

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

Not approved for repeated implantation (re-implantation) with this or any other cattle ear implant in growing beef heifers 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:

SPL UNCLASSIFIED SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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
Figure 1

SITE OF IMPLANTATION:

SPL UNCLASSIFIED SECTION

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
Figure 2

METHOD OF USE:

SPL UNCLASSIFIED SECTION

  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 3Figure 3

WITHDRAWAL PERIODS AND RESIDUE WARNINGS:

RESIDUE 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 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.

STORAGE CONDITIONS:

STORAGE AND HANDLING SECTION

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:

HOW SUPPLIED SECTION

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

QUESTIONS/COMMENTS?

SPL UNCLASSIFIED SECTION

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 www.fda.gov/reportanimalae

SPL UNCLASSIFIED SECTION

Made in Austria.

Distributed by
Intervet Inc. (d/b/a Merck Animal Health),
Rahway, NJ 07065.

Copyright © 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates.
All rights reserved.

Restricted Drug (California) – use only as directed.

Rev. 03/2025

MERCK
Animal Health

Approved by FDA under NADA # 140-992

235212 R2

PRINCIPAL DISPLAY PANEL - 10 x 10 Cartridge Implant Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Revalor®-H
(trenbolone acetate and estradiol implants)

For Growing Beef Heifers
Fed In Confinement
For Slaughter

Box of 10 × 10 Cartridge Implants

(100 implants)

Manufactured by a non-sterilizing process

MERCK
Animal Health

PRINCIPAL DISPLAY PANEL - 10 x 10 Cartridge Implant Carton
PRINCIPAL DISPLAY PANEL - 10 x 10 Cartridge Implant Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1669852estradiol 14 MG / trenbolone 140 MG Drug ImplantPSN6
1669854Revalor-H (trenbelone acetate 140 MG / estradiol 14 MG) Drug ImplantPSN6
1669854estradiol 14 MG / trenbolone 140 MG Drug Implant [Revalor]SBD6
1669852estradiol 14 MG / trenbolone 140 MG Drug ImplantSCD6
1669854Revalor-H (trenbelone acetate 140 MG / estradiol 14 MG) Drug ImplantSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57926-023-01Revalor-H10 in 1 CARTONIMPLANT106
57926-023-01Revalor-H10 in 1 CARTRIDGEIMPLANT106

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
estradiolACTIVE INGREDIENT4TI98Z838E1
trenbolone acetateACTIVE INGREDIENTRUD5Y4SV0S1
estradiolACTIVE MOIETY4TI98Z838E1
trenboloneACTIVE MOIETYP53R4420TR1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57926-02357926-023-01

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
ESTRADIOL4TI98Z838EACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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