GAINPRO 10 (BAMBERMYCINS) POWDER [HUVEPHARMA, INC.]

GAINPRO 10 (BAMBERMYCINS) POWDER [HUVEPHARMA, INC.]
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NDC 23243-2070-5
Set ID 590ff4a7-fab9-40a1-8075-7495b4c68a87
Category OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Packager Huvepharma, Inc.
Generic Name
Product Class
Product Number
Application Number NADA141034
  • MIXING DIRECTIONS AND PERMITTED CLAIMS

    Gainpro®

    BambermycinsType A Medicated Article

    PERMITTED CLAIMS AND LIMITATIONS

    Species                 Drug                 Level                 Claim(s)                 Limitations

    Cattle Fed in          Bambermycins 10 to 20               Increased rate        None
    Confinement for                             mg/hd/day**        of weight gain,
    Slaughter*                                                               improved feed
                                                                                  efficiency
    Pasture                Bambermycins   10 to 40              Increased rate        None
    Cattle*                                           mg/hd/day***      of weight gain

    *Only a single level of bambermycins (i.e. 2 grams bambermycins/ton) can be
    indicated on a feed tag. A different feed tag must be submitted for each level of
    bambermycins needed for your complete feeding program.

    CATTLE FED IN CONFINEMENT FOR SLAUGHTER:
    **THE APPROVED DOSAGE IN CATTLE FED IN CONFINEMENT FOR SLAUGHTER IS 10
    TO 20 MG OF BAMBERMYCINS/HD/DAY. The amount of bambermycins will range between
    1 and 4 grams per ton of feed depending upon the daily feed consumption of the cattle fed in
    confinement for slaughter. The amount of Type A Medicated Article added to the complete
    ration (Type C Medicated Feed) must be based on daily feed consumption, the number of
    animals in the pen and the level (10-20 mg/hd/day) of bambermycins being fed. From this
    information the grams of bambermycins per ton of feed can be calculated in order to fulfill
    feed assay requirements. No Type C Medicated Feed should be manufactured with less than
    1 g bambermycins/ton. Feed assays for bambermycins with expected levels below 1 g/t may
    not be accurate. See the following table for conversions from mg/hd/day to g/t.

    EXAMPLE OF CONVERTING THE BAMBERMYCINS CATTLE DOSAGE FROM
                            MG/HEAD/DAY TO GRAMS/TON*


                Mg
                       Average Feed            Grams                Bambermycinx
    Cattle         Consumption/         Bambermycins/         Fed Daily to
    Weight         Head/Day             Ton of Feed               each Animal

    Lbs.     Kg         Lbs.1                Low         High         Low             High
    400     181.4     10.0                 2.00         4.00         10.0             20.0
    500     226.8     14.0                 1.50         2.80         10.5             19.6
    600     272.2     17.0                 1.25         2.30         10.6             19.6
    700     317.5     20.0                 1.00         2.00         10.0             20.0
    800     362.9     22.0                 1.00         1.80         11.0             19.8
    900     408.2     23.0                 1.00         1.70         11.5             19.6
    1000   453.6     24.0                 1.00         1.60         12.0             19.2
    1100   499.0     25.0                 1.00         1.60         12.5             20.0
    1200   544.3     26.0                 1.00         1.50         13.0             19.5
    1300   589.7     27.0                 1.00         1.40         13.5             18.9
    *Dosage range is 10 to 20 mg/head/day             1Assumes as fed ad libitum
    consumption and average daily gain
    of 2.0 to 3.0 lbs./day

    Example Calculation—Amount of GAINPRO®-10 premix added to feed for a pen of cattle.
    Given: Average Weight—800 lbs.; Number in pen—100 hd.; Dosage—20 mg/hd/day; Daily
    Feed Consumption—22 lbs./day.
    • 100 hd x 20 mg = 2,000 mg or 2 grams bambermycins.
    • GAINPRO®-10 contains 10 grams bambermycins/lb., therefore add 0.2 pound of
    GAINPRO®-10 premix to the daily feed for this pen of 100 animals.
    • 22 lbs./day x 100 hd = 2,200 lbs. total feed consumption.
    • 2 grams bambermycins ÷ 2,200 lbs. = .000909 g/lb.
    • .000909 x 2,000 lbs. = 1.82 g bambermycins/ton of feed.

    MIXING DIRECTIONS:
    It is recommended that GAINPRO®-10 be diluted with a suitable grain carrier before addition
    to the final feed. A dilution of 1 part of GAINPRO®-10 and 9 parts grain carrier is the
    suggested working premix. The table below shows premix and working premix addition levels
    for various commonly used feeds.

            Pounds Premix To Be Added Per Ton
    Feed             Bambermycins Level         GAINPRO®-1   1-9 Working Premix

    Cattle Fed in         1 gram/ton                                0.1                                1
    Confinement         2 grams/ton                              0.2                                 2
    for Slaughter         3 grams/ton                              0.3                                 3
                                4 grams/ton                              0.4                                 4

    Thoroughly mix both working premix and finished feed to ensure complete and uniform
    distribution of the GAINPRO®-10.

    FEEDING DIRECTIONS:
    Feeds containing GAINPRO®-10 should be fed continuously in a complete feed. Complete
    feed for cattle fed in confinement for slaughter must be fed continuously at a rate of 10-20 mg
    bambermycins/hd/day from Type C Medicated Feed containing 1-4 g bambermycins/ton.

    TYPE B LIQUID FEEDS INTENDED FOR ADDITION TO DRY FEEDS FOR
    CONFINEMENT CATTLE

    •Type B Liquid Feeds should be in a pH range of 3.8 to 7.5 and should have a moisture
    content between 30 and 45%.
    •Type B Liquid Feeds must be mixed into the dry feed within 8 weeks of manufacture.
    •Type B Liquid Feeds can be manufactured containing 40.0 to 800.0 g of bambermycins/ton.
    Mixing directions into dry feed are as follows:

    Before feeding, the Type B Medicated Liquid feed must be thoroughly mixed with other feed
    materials to make a complete feed (Type C Medicated Feed). Examples of addition rates to
    complete feeds are shown in the following table.

        Addition Rate of Type B     Bambermycins (g/ton) in
    Bambermycins (g/ton) in         Liquid Feed (pounds/ton) to     Final Complete Feed
    Type B Liquid Feed
    Complete Feed                     (Type C Medicated Feed)
    40.0                                                         50.0                                          1.0
    40.0                                                         200.0                                         4.0

    100.0                                                        20.0                                          1.0
    100.0                                                        80.0                                           4.0

    400.0                                                         5.0                                           1.0
    400.0                                                       20.0                                           4.0

    800.0                                                         2.5                                           1.0
    800.0                                                       10.0                                           4.0
    The complete dry feed (Type C Medicated Feed) may only be fed to cattle in confinement for
    slaughter and must be fed within one week after mixing.

    PASTURE CATTLE:
    ***THE APPROVED DOSAGE IN PASTURE CATTLE IS 10 TO 40 MG OF BAMBERMYCINS/
    HD/DAY. Daily intakes of bambermycins in excess of 20 mg/head/day have not
    been shown to be more effective than 20mg/head/day. Blend 0.8 pound of GAINPRO®-10
    with 1999.2 pounds of suitable grain carrier. This supplemental feed will contain 4 mg bambermycins
    per pound (8 g/ton). This supplemental feed can be fed at a rate of 2.5 to 10
    pounds per head per day to achieve a daily intake of 10 to 40 mg bambermycins/head/day.
    See the following table for additional examples of conversion from mg/hd/day to g/t.

    MIXING DIRECTIONS:
    It is recommended that GAINPRO®-10 be diluted with a suitable grain carrier to provide a
    supplemental feed. The table below shows examples of premix addition levels.

    Pounds
    GAINPRO®-10
    Feed Bambermycins LevelTo Be Added Per TonFeeding Rate
    Pasture             2 grams/ton                         0.2                         10.0 lb./hd/day
    Cattle                4 grams/ton                         0.4                         5.0-10.0 lb./hd/day
                            8 grams/ton                         0.8                         2.5-10.0 lb./hd/day
                           20 grams/ton                        2.0                         1.0-4.0 lb./hd/day
                           40 grams/ton                        4.0                         1.0-2.0 lb./hd/day
                           80 grams/ton                        8.0                         1.0 lb./hd/day

    Thoroughly mix both working premix and supplemental feed to ensure complete and uniform
    distribution of the GAINPRO®-10.

    FEEDING DIRECTIONS:

    Feed for Pasture Cattle must be fed continuously at a rate of 10-40 mg bambermycins/hd/day
    in at least one pound and not more than 10 pounds of Type C Medicated Feed containing 2-
    40 g bambermycins/ton. Daily intakes of bambermycins in excess of 20 mg/head/day have
    not been shown to be more effective than 20 mg/head/day.

    FREE-CHOICE (SELF-FED) SUPPLEMENT:
    Free-choice supplements must be formulated to provide not less than 10 mg nor more than
    40 mg bambermycins per head per day. An FDA approved formula must be used to manufacture
    free-choice medicated feeds containing bambermycins. Feed mills that use a proprietary formula
    are required to be licensed.

  • Bag Label Image

    GAINPRO®10

    For increased rate of weight gain and
    improved feed efficiency in cattle fed in
    confinement for slaughter. For increased rate
    of weight gain in pasture cattle (slaughter,
    stocker and feeder cattle, and dairy and beef
    replacement heifers).

    ACTIVE INGREDIENTS
    Bambermycins 10 grams per pound (22
    grams per kilogram)

    INGREDIENTS
    Roughage products and/or calcium carbonate,
    dried bambermycins fermentation product,
    mineral oil.

    MIXING DIRECTIONS AND PERMITTED
    CLAIMS ON REVERSE SIDE.
    FOR USE IN MANUFACTURED FEEDS ONLY.
    NOT FOR HUMAN USE
    Restricted Drug (California)-
    use only as directed

    Net Weight—50 pounds (22.68 kg)

    Distributed by:
    HUVEPHARMA, INC.
    Peachtree City, GA 30269
    NADA # 141-034, Approved by FDA

    Bag Label Image

  • INGREDIENTS AND APPEARANCE
    GAINPRO  10
    bambermycins powder
    Product Information
    Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:23243-2070
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BAMBERMYCINS (UNII: PP922A42V2) (BAMBERMYCINS - UNII:PP922A42V2) BAMBERMYCINS22 g  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHOXYQUIN (UNII: 9T1410R4OR)  
    Product Characteristics
    Colorbrown ((Off White to Tan)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-2070-522.68 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14103408/22/2016
    Labeler - Huvepharma, Inc. (619153559)
    Registrant - Huvepharma EOOD (552691651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huvepharma, Inc.883128204manufacture, analysis, label, pack, medicated animal feed manufacture

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