Label: ZOAMIX- dinitolmide powder

  • Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated July 7, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Zoalene
    Type A Medicated Article
    Coccidiostat

  • DESCRIPTION

    Active drug ingredient
     Zoalene (3,5-dinitro-o-toluamide) 25%
    Inactive ingredients
     Roughage product, ground limestone, mineral oil 75%
  • INDICATIONS & USAGE

    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 Zoamix 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 Zoamix per 2,000 lb (909 kg) of finished product to produce a feed containing 0.0125% zoalene. Zoamix 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:

    Starter ration

    Grower ration*

    Growing condition

    % Zoalene per ton

    Zoamix to be added per ton of feed

    % Zoalene in feed

    Zoamix 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

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

    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 Zoamix 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 Zoamix per 2,000 lbs (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.

  • STORAGE AND HANDLING

    Store below 37°C

  • SPL UNCLASSIFIED SECTION

    Restricted Drug (California) - use only as directed. Not for human use.
    Approved by FDA under NADA # 011-116

    zoetis

    Manufactured by Zoetis LLC,
    Salisbury, MD 21801

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Product of China

    Net wt 50 LB (22.68 kg)

    Take Time logo

    40026637

  • PRINCIPAL DISPLAY PANEL - 22.68 kg Bag

    22.68 kg Bag
  • INGREDIENTS AND APPEARANCE
    ZOAMIX 
    dinitolmide powder
    Product Information
    Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:54771-1116
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1116-122.68 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA01111605/04/1960
    Labeler - Zoetis Inc. (828851555)