Component E-C

Manufacturer
Elanco US Inc.
Effective date
2024-11-20
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:43:56

Label at a glance#

ProductComponent E-C
Active ingredientPROGESTERONE, ESTRADIOL BENZOATE
Label structure11 sections

Dosage and administration

Administer 1 implant - the entire contents of one cartridge cell (4 pellets) - subcutaneously in the back of the middle third of the ear. Study and carefully follow at all times the " IMPLANTING INSTRUCTIONS " presented below, 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 al...

Storage and handling

Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT refrigerate – avoid excessive heat and humidity. Discard open foil pouches.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Elanco™

Component™ E-C

(progesterone and estradiol benzoate implants)

BEEF CALVES 45 DAYS OF AGE AND OLDER AND WEIGHING UP TO 400 LBS

Each implant consists of 100 mg progesterone USP and 10 mg estradiol benzoate

IMPLANTS FOR BEEF CALVES 45 DAYS OF AGE AND OLDER AND WEIGHING UP TO 400 LBS

20 dose Cartridge Belt

Use with a Component Implanter

DESCRIPTION:

DESCRIPTION SECTION

Each cartridge belt holds 20 doses of Component E-C (progesterone and estradiol implant) Implants. Each dose of 4 pellets contains a total of 100 mg progesterone USP and 10 mg estradiol benzoate.

INDICATIONS FOR USE:

INDICATIONS & USAGE SECTION

For increased rate of weight gain in beef calves 45 days of age and older and weighing up to 400 lbs.

This implant is not approved for repeated implantation (reimplantation) with this or any other cattle ear implant as safety and effectiveness has not been evaluated.

Do not use in calves less than 45 days of age or veal calves because effectiveness and safety have not been evaluated.

Do not use in animals intended for subsequent breeding, or in dairy cows.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Administer 1 implant - the entire contents of one cartridge cell (4 pellets) - subcutaneously in the back of the middle third of the ear. Study and carefully follow at all times the "IMPLANTING INSTRUCTIONS" presented below, 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.

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 45 days of age, dairy calves, and veal calves. Do not use in bull calves intended for reproduction. 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 in 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:

USER SAFETY WARNINGS SECTION

Not for use in humans. Keep out of reach of children.

ANIMAL SAFETY WARNINGS:

WARNINGS SECTION

Bulling has occasionally been reported in implanted steers and heifers. Vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered Component E-C implants.

Restricted Drug (California) - Use Only as Directed

IMPLANTING INSTRUCTIONS:

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Loading the Implanter

Load the implanter following the instructions supplied with each implanter.

Loading the implanter figure
Loading the implanter figure

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.

Restraining the animal figure
Restraining the animal figure

Prepare the Implant Site

Scrub the back side of the ear (implant site) with a piece of clean absorbent cotton or brush 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 and at least a needle length away from the intended deposition site. Avoid injuring the large arteries, veins and cartilage of the ear.

Where to implant figure
Where to implant figure

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.

Inserting the needle figure
Inserting the needle figure

Implant the Pellets

After inserting the needle fully in the correct implant 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 a single dose are designed to permit absorption of the hormones after implantation to stimulate good weight gain. Broken or crushed pellets may lead to undesirable side effects such as bulling, rectal and vaginal prolapse, etc., as noted in the ANIMAL SAFETY WARNINGS.

STORAGE CONDITIONS:

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15° to 30°C (59° to 86°F) DO NOT refrigerate – avoid excessive heat and humidity.

Discard open foil pouches.

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 110-315

Manufactured by a non-sterilizing process.

Component, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2024 Elanco or its affiliates

Distributed by Elanco US Inc., Greenfield, IN 46140, USA

May 2024

 

PA104145X          AH0792

Package/Label Principal Display Panel – Cartridge Belt Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

Component™ E-C

(progesterone and estradiol benzoate implants)

BEEF CALVES 45 DAYS OF AGE AND OLDER
AND WEIGHING UP TO 400 LBS

One 20-Dose
Cartridge Belt

Component E-C (progesterone and estradiol benzoate implants) Cartridge Belt Label
Component E-C (progesterone and estradiol benzoate implants) Cartridge Belt Label
Component E-C (progesterone and estradiol benzoate implants) Cartridge Belt Label
Component E-C (progesterone and estradiol benzoate implants) Cartridge Belt Label

Package/Label Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™

Component™ E-C

(progesterone and estradiol benzoate implants)

BEEF CALVES 45 DAYS OF AGE AND OLDER
AND WEIGHING UP TO 400 LBS

100 IMPLANTS

Component E-C (progesterone and estradiol benzoate implants) Carton Label
Component E-C (progesterone and estradiol benzoate implants) Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1648169progesterone 100 MG / estradiol benzoate 10 MG Drug ImplantPSN2
1648169estradiol 3-benzoate 10 MG / progesterone 100 MG Drug ImplantSCD2
1648169estradiol benzoate 10 MG / progesterone 100 MG Drug ImplantSY2

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
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
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
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0792-1Component E-C1 in 1 POUCHIMPLANT12
58198-0792-1Component E-C5 in 1 CARTONIMPLANT52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-0792COMPONENT E-C (PROGESTERONE AND ESTRADIOL BENZOATE) IMPLANT [ELANCO US INC.]22 package rows20241204_cf3fa045-80c8-4a08-9667-3208bf3b42a8.zip

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
58198-079258198-0792-1

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
PROGESTERONE4G7DS2Q64YACTIB
ESTRADIOL BENZOATE1S4CJB5ZGNACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROGESTERONEPROGESTERONEREMEDYREPACK INC.947ebb7c-492b-4b83-aa1c-81e282df64212026-08-28Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEPreferred Pharmaceuticals Inc.404e0b45-339b-4304-8e33-5f4ffe8f8e252026-08-24Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ENDOMETRINPROGESTERONEFerring Pharmaceuticals Inc.2ba50fa9-b349-40cb-9a4b-1af8faa4ec092026-07-29Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEREMEDYREPACK INC.f7615864-be6e-47b4-bf35-145a361d7cc62026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PrometriumPROGESTERONEAcertis Pharmaceuticals, LLC1cf237ff-c4f8-4faa-a7aa-77599c8568892026-07-23Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONERedpharm Drug5743b2e4-093f-c59a-e063-6394a90aae2b2026-07-23Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONENorthStar Rx LLCf392c6d9-1420-4735-aa01-f434da9b31b32026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEA-S Medication Solutionsbc62ae6d-b609-432d-863f-a8ecd223d69a2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEGolden State Medical Supply, Inc.312db3af-9dd2-d5e4-e063-6394a90af9992026-06-18Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEAvKARE42c84fec-e5eb-78f7-e063-6294a90a4c0e2026-06-16Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack1ba10f9d-6e91-4954-ac91-23adcf8805b02026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack74a7619a-8f74-4889-96f6-5bae478543e82026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEBionpharma Inc.41b3c3a7-5fb8-4451-a96c-2bd02613c0212026-05-29Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONESun Pharmaceutical Industries, Inc.fcdde0d0-4329-4725-a76b-684f9d97fe952026-05-19Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEAvKARE1637ac18-3a37-f3d5-e063-6394a90af1572026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEA-S Medication Solutions566584fc-c76a-4e42-a62e-109a2903b9392026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
Natural ProgesteronePROGESTERONEBioActive Nutritional, Inc.772629aa-af5e-4493-aaf2-3c75bfd7d8c22026-05-05WarningsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEHikma Pharmaceuticals USA Incd8bcc439-c21d-4eeb-9159-f51e0c60bd702026-04-28Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONE VAGINAL INSERTSPROGESTERONEGlenmark Pharmaceuticals Inc., USA41682665-e889-4e2a-9382-88f6bcc302372026-04-17Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBioActive Nutritional, Inc.cddb5afa-9825-418d-acf6-cffbb0fc39c32026-03-10WarningsName fallback
generic name: PROGESTERONE

Reported adverse events (FAERS/openFDA)#

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