ZOASHIELD- dinitolmide granule 
Elanco US Inc.

----------

Elanco

ZoaShield™ 25%™

Net wt. 50 LB (22.68 kg)

(zoalene Type A medicated article)

Coccidiostat

Active Drug Ingredient

Zoalene (3,5-dinitro-o-toluamide) 25%

Inactive Ingredients

Roughage product, calcium carbonate, mineral oil 75%

For use in preparation of feeds for chickens and turkeys only. Livestock remedy.

Indications

Broiler Chickens: For prevention and control of coccidiosis.

Replacement Chickens: For development of active immunity to coccidiosis.

Growing Turkeys: For prevention and control of coccidiosis.

Directions

It is suggested that a mixture of ZoaShield 25% and some feed ingredient be prepared prior to mixing in with the finished ration. This will ensure thorough and even distribution in the feed.

For chickens grown for meat purposes:

Use 1 lb (454 g) of ZoaShield 25% per 2,000 lb (909 kg) of finished product to produce a feed containing 0.0125% zoalene. ZoaShield 25% should be thoroughly blended into the finished feed. Feed containing zoalene should be fed continuously as the only ration from the time chicks are placed in floor pens until they are slaughtered for meat.

For replacement chickens:

Feed containing zoalene can be used in a program to raise replacement birds. When used under conditions of exposure to coccidiosis, it will allow immunity to develop adequately to protect against losses due to the disease when the birds are placed on nonmedicated feed for egg laying purposes. The following chart outlines the type of feeding program to follow where complete formulated feed is the sole ration:

*Grower ration not to be fed to birds over 14 weeks of age.

Starter rationGrower ration*
Growing condition% Zoalene per tonZoaShield 25% to be added per ton of feed% Zoalene in feedZoaShield 25% to be added
per ton of feed
(lb)(g)(lb)(g)
Severe exposure to coccidiosis expected0.0125 1 454 0.0083
to
0.0125
2/3
to
1
303
to
454
Light to moderate exposure to coccidiosis expected0.0083
to
0.0125
2/3
to
1
303
to
454
0.004
to
0.0083
1/3
to
2/3
151
to
303

For turkeys grown for meat purposes only:

When turkey poults are reared in confinement and severe exposure to coccidiosis is usually a problem, use 1½ lb (681 g) of ZoaShield 25% per ton (2,000 lb) of feed to produce a finished feed containing 0.0187% zoalene. Under the usual conditions of rearing turkey poults, or when turkey poults are on range, use 1 lb (454 g) of ZoaShield 25% per 2,000 lb (909 kg) of feed to produce a finished feed containing 0.0125% zoalene. The feed containing zoalene should be fed continuously until the birds are 14 to 16 weeks of age.

Combinations with other drugs

Use only in accordance with the current New Animal Drug Regulation for zoalene, Section 558.680 of the Regulations promulgated under the Federal Food, Drug and Cosmetic Act.

Cautions

Not to be fed to laying birds.

Consult a veterinarian or poultry pathologist if losses exceed 0.5% in a two-day period.

Avoid inhaling dust.

Avoid contact with eyes.

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Elanco, 1-800-428-4441. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Store at or below 25°C. Excursions permitted to 40°C.

Restricted Drug (California) - use only as directed. Not or human use.

Approved by FDA under ANADA # 200-690

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

Manufactured for:
Elanco US Inc.
Greenfield, IN 46140, USA

YL103082X

Principal Display Panel - 50 lb Bag Label

Elanco

ZoaShield25%

Net wt. 50 LB (22.68 kg)

(zoalene Type A medicated article)

Coccidiostat

Figure
ZOASHIELD 
dinitolmide granule
Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:58198-7636
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DINITOLMIDE (UNII: AOX68RY4TV) (DINITOLMIDE - UNII:AOX68RY4TV) DINITOLMIDE5.67 kg  in 22.68 kg
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate (UNII: H0G9379FGK)  
Mineral Oil (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58198-7636-122.68 kg in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20069009/18/2020
Labeler - Elanco US Inc. (966985624)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Rongyao Biotech Co., Ltd.529047233API MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Pharmgate Inc.079628468MANUFACTURE, PACK, LABEL

Revised: 1/2021
Document Id: 2acd398b-1554-4aac-80bb-690baeeb1e97
Set id: 6df2cf30-5730-447d-be81-7241414f4abf
Version: 2
Effective Time: 20210122
 
Elanco US Inc.