Gainpro

Manufacturer
Huvepharma, Inc. | Huvepharma EOOD
Effective date
2024-05-08
Label type
OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:43:06

Label at a glance#

ProductGainpro 10
Active ingredientBAMBERMYCINS
Label structure12 sections

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

Label contents#

Full prescribing information#

RESIDUE WARNING SECTION

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

ADVERSE REACTIONS SECTION

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
www.fda.gov/reportanimalae.

VETERINARY INDICATIONS SECTION

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.

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

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

VETERINARY INDICATIONS SECTION

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

USER SAFETY WARNINGS SECTION

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

Restricted Drug (California) – use only as directed

STORAGE AND HANDLING SECTION

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 & USAGE SECTION

Indications TableIndications Table

INDICATIONS & USAGE SECTION

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 TableExample 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 SECTION

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 1Feed 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 2Feed 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®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gainpro 10 - Front LabelGainpro 10 - Front Label

Gainpro 10 back labelGainpro 10 back label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23243-2070-5Gainpro1022.68 kg in 1 BAGPOWDER22.687

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23243-2070GAINPRO 10 (BAMBERMYCINS TYPE A MEDICATED ARTICLE) POWDER [HUVEPHARMA, INC.]71 package rows20240515_590ff4a7-fab9-40a1-8075-7495b4c68a87.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BAMBERMYCINSACTIVE INGREDIENTPP922A42V22
BAMBERMYCINSACTIVE MOIETYPP922A42V22
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23243-207023243-2070-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAMBERMYCINSPP922A42V2ACTIB
MINERAL OILT5L8T28FGPIACT
ETHOXYQUIN9T1410R4ORIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.