Label: ZOASHIELD- dinitolmide granule
- NDC Code(s): 58198-7636-1
- Packager: Elanco US Inc.
- Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated January 22, 2021
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- Active Drug Ingredient
- Inactive Ingredients
- Indications
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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.
S tarter ration G rower 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
0.01252/3
to
1303
to
454Light to moderate exposure to coccidiosis expected 0.0083
to
0.01252/3
to
1303
to
4540.004
to
0.00831/3
to
2/3151
to
303For 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, USAYL103082X
- Principal Display Panel - 50 lb Bag Label
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INGREDIENTS AND APPEARANCE
ZOASHIELD
dinitolmide granuleProduct Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:58198-7636 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DINITOLMIDE (UNII: AOX68RY4TV) (DINITOLMIDE - UNII:AOX68RY4TV) DINITOLMIDE 5.67 kg in 22.68 kg Inactive Ingredients Ingredient Name Strength Calcium Carbonate (UNII: H0G9379FGK) Mineral Oil (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-7636-1 22.68 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200690 09/18/2020 Labeler - Elanco US Inc. (966985624) Establishment Name Address ID/FEI Business Operations Zhejiang Rongyao Biotech Co., Ltd. 529047233 API MANUFACTURE Establishment Name Address ID/FEI Business Operations Pharmgate Inc. 079628468 MANUFACTURE, PACK, LABEL
