Animal NDC 58198-7636-1 Zoashield

Dinitolmide

Animal Product Information

Field Name	Field Value
Animal NDC Code	58198-7636-1
Proprietary Name	Zoashield 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	Dinitolmide 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	Elanco Us Inc.
Product Type	Otc Type A Medicated Article Animal Drug
Usage Information	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.
Active Ingredient(s)	Dinitolmide
Marketing Category	ANADA - ABBREVIATED 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	ANADA200690 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.

Zoashield Images

ZoaShield 25% (zoalene Type A medicated article) Coccidiostat Label - zoa00 0000 01

Zoashield 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.

Other
Active Drug Ingredient
Inactive Ingredients
Warnings
Indications For Use
Directions
Combinations With Other Drugs
Cautions
Withdrawal Periods
Questions/Comments?
Storage And Handling
Principal Display Panel - 50 Lb Bag Label

Other

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%

Warnings

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

Indications For Use

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 broiler chickens:

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 ration		Grower ration*
Growing condition	% Zoalene per ton	ZoaShield 25% to be added per ton of feed		% Zoalene in feed	ZoaShield 25% to be added per ton of feed
		(lb)	(g)		(lb)	(g)
Severe exposure to coccidiosis expected	0.0125	1	454	0.0083 to 0.0125	2/3 to 1	303 to 454
Light to moderate exposure to coccidiosis expected	0.0083 to 0.0125	2/3 to 1	303 to 454	0.004 to 0.0083	1/3 to 2/3	151 to 303

For growing turkeys:

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.

Withdrawal Periods

No withdrawal period required when used according to labeling.

Questions/Comments?

To report side effects, access medical information, or obtain product information, call Elanco US Inc. at 1-800-428-4441.

For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Storage And Handling

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

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

Approved by FDA under ANADA # 200-690

Manufactured for: Elanco US Inc. Indianapolis, IN 46221

YL104350X

Principal Display Panel - 50 Lb Bag Label