Gainpro 10: Product Information

GAINPRO 10- bambermycins powder
Huvepharma, Inc.

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

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.

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

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

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

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

Restricted Drug (California) – use only as directed

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
(click image for full-size original)

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
(click image for full-size original)

*Dosage range is 10 to 20 mg/head/day
1 Assumes 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.

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 commonlyused feeds.

Feed Table 1
(click image for full-size original)

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 MedicatedFeed 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 tocomplete 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®-10and working intermediate pre-blend addition levels and feeding rates.

Feed Table 2
(click image for full-size original)

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®

Rev. 02-20221114113001

Gainpro 10 -- Front Label
(click image for full-size original)

Gainpro 10 back label
(click image for full-size original)
GAINPRO 10 bambermycins powder
Product Information
Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:23243-2070
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BAMBERMYCINS (BAMBERMYCINS) BAMBERMYCINS 22 g in 1 kg
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL
ETHOXYQUIN
Product Characteristics
Color brown ((Off White to Tan)) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23243-2070-5 22.68 kg in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141034 08/22/2016
Labeler — Huvepharma, Inc. (619153559)
Registrant — Huvepharma EOOD (552691651)
Establishment
Name Address ID/FEI Operations
Huvepharma, Inc. 883128204 manufacture, analysis, label, pack, medicated animal feed manufacture

Revised: 05/2022 Huvepharma, Inc.

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