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

SACOX 60 (SALINOMYCIN) POWDER [HUVEPHARMA, INC.]
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NDC 23243-2080-5
Set ID b55d5494-6ef2-4c68-be0c-2168fa325edc
Category OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Packager Huvepharma, Inc.
Generic Name
Product Class
Product Number
Application Number ANADA200075
  • TOP LEFT AND BOTTOM SECTIONS OF LABEL

    TYPE A MEDICATED ARTICLE

    Sacox 60

    SALINOMYCIN SODIUM

    For Use in Broiler Chickens Only


    Batch No.:

    Expiration Date:

    Distributed by:
    Huvepharma, Inc.
    Peachtree City, GA 30269

    ANADA #200-075
    Approved by FDA

  • Active Drug Ingredient

    Salinomycin equivalent to 60 grams salinomycin sodium activity per pound


  • Ingredients

    Calcium Carbonate, Mineral Oil, Calcium Silicate, Silicon Dioxide and Microtracers

  • VETERINARY INDICATIONS

    Medicated Premix

    Equivalent to 60 grams salinomycin sodium activity per
    pound. For the prevention of coccidiosis caused
    by Eimeria tenella, E. necatrix, E.
    acervulina
    , E. maxima, E. brunetti and
    E. mivati.

  • WHEN USING

    Important
    Must be Thoroughly Mixed in Feeds
    Before Use. Not approved for Use With
    Pellet Binders.

    Restricted Drug (California)- Use Only as Directed


    For Use in Broiler Chickens Only


    Dose
    Sacox 60 can be used to provide concentrations of
    salinomycin ranging from 40 to 60 g/ton. The dosage
    should be adjusted to meet the severity of the coccidial
    challenge,which varies with environmental and management
    conditions.

    Mixing Directions
    Thoroughly mix the correct amount of the premix
    according to the directions below with an amount of non-medicated
    feed to provide the level of salinomycin per
    ton of feed.

    Salinomycin Sodium Activity     Amount of Sacox Premix
            (grams per ton)                       Per Ton of Feed

                    40                                         11 ounces
                    45                                         12 ounces
                    50                                         13.5 ounces
                    55                                         14.5 ounces
                    60                                            1 pound


    Feeding Directions
    Feed continuously as the only ration

  • WARNINGS

    Warning

    No withdrawal required. Do not feed to laying chickens.

    May be fatal if accidentally fed to adult turkeys or

    to horses.

  • Warning


    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.
    contact occurs, immediately rinse thoroughly
    with water.

  • Storage

    Store at or below 25° C (77° F), excursions permitted to 40° C (104° F).
    Avoid prolonged exposure to high humidity.

  • 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:23243-2080
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALINOMYCIN (UNII: 62UXS86T64) (SALINOMYCIN - UNII:62UXS86T64) SALINOMYCIN132 g  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-2080-522.68 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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