Label: GAINPRO 10- bambermycins type a medicated article powder

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

Drug Label Information

Updated May 8, 2024

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

  • RESIDUE WARNING

          WITHDRAWAL PERIODS
    No withdrawal period is required when
            used according to labeling.

  • ADVERSE REACTIONS

    To report suspected adverse drug events, for technical assistance or to obtain a copy
    of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or
    www.huvepharma.us. For additional information about adverse drug experience
    reporting for animal drugs, contact FDA at 1-888-FDA-VETS or
    http://www.fda.gov/reportanimalae.

  • VETERINARY INDICATIONS

    INDICATIONS FOR USE:
    For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers
    fed in confinement for slaughter. For increased rate of weight gain in growing beef steers and
    heifers on pasture (stocker, feeder, and slaughter), and replacement beef and dairy heifers on pasture.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:
    Bambermycins 10 grams per pound (22 grams per kilogram)

  • INACTIVE INGREDIENT

    INGREDIENTS:
    Roughage products and/or calcium carbonate, dried bambermycins fermentation product,
    ethoxyquin (a preservative), mineral oil.

  • VETERINARY INDICATIONS

    MIXING DIRECTIONS AND INDICATIONS FOR USE ON REVERSE SIDE.
    FOR USE IN MANUFACTURED FEEDS ONLY.

  • USER SAFETY WARNINGS

    USER SAFETY WARNING:
    Not for human use. Keep out of reach of children.

    Restricted Drug (California) – use only as directed

  • STORAGE AND HANDLING

    STORAGE:
    Store at or below 25°C (77°F), excursions permitted to 40°C (104°F).

    Approved by FDA under NADA # 141-034

    Net Weight – 50 pounds (22.68 kg)

    HUVEPHARMA®

    Distributed by:
    HUVEPHARMA, INC.
    Peachtree City, GA 30269

  • INDICATIONS FOR USE

    Indications Table

  • INDICATIONS & USAGE

    GROWING BEEF STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER:
    **THE APPROVED DOSE IN GROWING BEEF STEERS AND HEIFERS 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. 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.
    See the following table for conversions from mg/hd/day to g/t.

    Example Dosage Form Table

    *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 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 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.

  • INDICATIONS & USAGE

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

    Feed Table 1

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

    FEEDING DIRECTIONS:
    Feed continuously in a complete feed at the rate of 10-20 mg bambermycins/head/day from
    the Type C Medicated Feed containing 1-4 g bambermycins/ton.

    TYPE B LIQUID MEDICATED FEED INTENDED FOR ADDITION TO DRY FEEDS FOR
    GROWING BEEF STEERS AND HEIFERS FED IN CONFINEMENT FOR SLAUGHTER:
    •Type B Liquid Medicated Feed 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 Medicated Feed must be mixed into the dry feed within 8 weeks of manufacture.
    •Type B Liquid Medicated Feed 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 Liquid Medicated 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.

    Bambermycins (g/ton) in
    Type B Liquid
    Medicated Feed

    Addition Rate of Type B
    Liquid Medicated Feed
     (lb/ton) to Complete Feed

    Bambermycins (g/ton) in
    Final 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 growing beef steers and heifers
    fed in confinement for slaughter and must be fed within one week after mixing.

    GROWING BEEF STEERS AND HEIFERS ON PASTURE (STOCKER, FEEDER, AND SLAUGHTER),
    AND REPLACEMENT BEEF AND DAIRY HEIFERS ON PASTURE:
    ***THE APPROVED DOSE IN GROWING BEEF STEERS AND HEIFERS ON PASTURE (STOCKER,
    FEEDER, AND SLAUGHTER), AND REPLACEMENT BEEF AND DAIRY HEIFERS ON PASTURE 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 20 mg/head/day.

    MIXING DIRECTIONS:
    It is recommended that GAINPRO®-10 be diluted with a feed ingredient before addition to the
    supplemental feed. A dilution of 1 part of GAINPRO®-10 and 9 parts feed ingredient is the suggested
    working intermediate pre-blend. The table below shows examples of GAINPRO®-10
    and working intermediate pre-blend addition levels and feeding rates.

    Feed Table 2

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

    To manufacture Type B medicated feeds containing 100.0 to 800.0 g/ton bambermycins
    mix 10 to 80 lbs. of GAINPRO®-10 with 1990 to 1920 lbs. of non-medicated feed.

    To manufacture Type C medicated feeds containing 2.0 to 80.0 g/ton bambermycins from
    Type B medicated feeds mix:
          40 to 1600 lbs. of Type B feed containing 100 g/ton bambermycins with 1960 to 400 lbs.
          of non-medicated feed, or
          5 to 200 lbs. of Type B feed containing 800 g/ton bambermycins with 1995 to 1800
          lbs. of non-medicated feed.
    Thoroughly mix both Type B medicated feed and finished feed to ensure complete and
    uniform distribution of the GAINPRO®-10.

    FEEDING DIRECTIONS FOR HAND-FED TYPE C MEDICATED FEED:
    Feed continuously on a hand-fed basis at a rate of 10 to 40 mg bambermycins per head
    per day. The drug must be contained in 1 to 10 lbs. of supplemental Type C medicated
    feed containing 2 to 80 g bambermycins per 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.

    TYPE C FREE-CHOICE MEDICATED FEED:
    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.

    HUVEPHARMA®

  • PRINCIPAL DISPLAY PANEL

    Gainpro 10 - Front Label

    Gainpro 10 back label

  • INGREDIENTS AND APPEARANCE
    GAINPRO  10
    bambermycins type a medicated article 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 (552671651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huvepharma, Inc.883128204manufacture, analysis, label, pack, medicated animal feed manufacture