SACOX 60 (SALINOMYCIN) POWDER [HUVEPHARMA, INC.]

SACOX 60 (SALINOMYCIN) POWDER [HUVEPHARMA, INC.]
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NDC 23243-2050-5
Set ID 124e6803-6f35-42dd-98b3-75e956f5be2a
Category OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Packager Huvepharma, Inc.
Generic Name
Product Class
Product Number
Application Number ANADA200075
  • FRONT PANEL

    Brand of salinomycin sodium
    Type A Medicated Article

    For use in broiler, roaster, replacement
    (breeder and layer) chickens, and quail only

  • Active Drug Ingredient

    Salinomycin equivalent to 60 grams salinomycin sodium activity per pound

    For use in manufacturing medicated feeds only
  • Other Ingredients

    Calcium Carbonate, Mineral Oil, Calcium Silicate and Silicon Dioxide

  • Indications for Use

    Broiler, roaster and replacement (breeder and layer) chickens

    Use Sacox 60 to provide salinomycin sodium concentrations ranging from 40-60 g/ton (0.0044% to 0.0066%) for the prevention of coccidiosis in broiler, roaster and replacement chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati. The dosage should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions.


    Quail

    Use Sacox 60 to provide salinomycin sodium concentrations of 50 g/ton (0.0055%) for the prevention of coccidiosis in quail caused by Eimeria dispersa and E. lettyae.

    For use in manufacturing medicated feeds only

  • WHEN USING

    Mixing Directions
    Thoroughly mix Sacox® 60 with non-medicated feed to provide the
    level of salinomycin sodium per ton as indicated in the table below.

     Saliomycin Sodium

    Activity                                                           

    Amount of Sacox® 60 Type A Medicated
    Article (60 g/lb) Per Ton of Feed

    (grams per ton) Lbs Grams
    400.67304 
    45 0.75 341 
    50 0.83 377 
    55 0.92 418 
    60 1.00 454 

    Feeding DirectionsFeed continuously as the sole ration

    Important
    Must be thoroughly mixed in feeds before use. Not approved for use with pellet binders.

  • GENERAL PRECAUTIONS

    Caution

    No withdrawal required. May be fatal if accidentally fed to adult turkeys or to horses

  • WARNINGS

    Warning

    Do not feed to laying hens producing eggs for human consumption. When mixing and handling Sacox 60 premix, use protective clothing, impervious gloves, eye protection, and an approved dust respirator. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water

  • STORAGE AND HANDLING

    Storage and Handling

    Store in a cool, dry place

    ANADA #200-075, Approved by FDA

    Distributed by:

    Huvepharma, Inc.

    Peachtree City, GA 30269

    Net Wt. 50 lb. (22.68 kg)

  • Bag Label Image

    Bag Label Image

  • INGREDIENTS AND APPEARANCE
    SACOX 60 
    salinomycin powder
    Product Information
    Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:23243-2050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALINOMYCIN (UNII: 62UXS86T64) (SALINOMYCIN - UNII:62UXS86T64) SALINOMYCIN60 g  in 0.45 kg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite ((Off White to Tan)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-2050-522.68 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20007506/29/2009
    Labeler - Huvepharma, Inc. (619153559)
    Registrant - Huvepharma EOOD (552691651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huvepharma, Inc.883128204manufacture, analysis, medicated animal feed manufacture

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