Flavomycin
- Manufacturer
- Huvepharma, Inc. | Huvepharma EOOD
- Effective date
- 2024-05-01
- Label type
- OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 02:43:06
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
FLAVOMYCIN® 4
(bambermycins Type A medicated article)
ADVERSE REACTIONS SECTION
ANTIBIOTIC
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 broiler chickens,
growing-finishing swine and growing turkeys.
OTC - ACTIVE INGREDIENT SECTION
ACTIVE DRUG INGREDIENT
Bambermycins 4 grams per pound (8.8 grams per kilogram)
INACTIVE INGREDIENT SECTION
INGREDIENTS
Roughage products and/or calcium carbonate, dried bambermycins fermentation product,
ethoxyquin (a preservative), mineral oil.
MIXING DIRECTIONS AND INDICATIONS ON REVERSE SIDE
RESIDUE WARNING SECTION
WITHDRAWAL PERIODS
No withdrawal period is required when used according to labeling.
USER SAFETY WARNINGS SECTION
FOR USE IN MANUFACTURED FEEDS ONLY
USER SAFETY WARNINGS
Not For Human Use
Keep out of reach of children.
Restricted Drug (California) – Use only as directed
Net Weight – 50 pounds (22.68 kg)
Distributed by:
HUVEPHARMA, INC.
Peachtree City, GA 30269
VETERINARY INDICATIONS SECTION
FLAVOMYCIN® 4
(bambermycins Type A Medicated Article)
ANTIBIOTIC
INDICATIONS FOR USE
Species | Bambermycins g/ton in Type C medicated feed | Indication(s) | |||
Broiler Chickens | 1-2* | Increased rate of weight gain; improved feed efficiency | |||
Growing- Finishing Swine | 2 | Increased rate of weight gain; improved feed efficiency | |||
2-4* | Increased rate of weight gain | ||||
Growing Turkeys | 2 | Increased rate of weight gain; improved feed efficiency | |||
1-2* | Improved feed efficiency | ||||
*Only a single level of bambermycins (e.g., 4 grams/ton bambermycins) 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. | |||||
MIXING DIRECTIONS: It is recommended that Flavomycin® 4 be diluted with a suitable grain carrier before addition to the final feed. A dilution of 1 part of Flavomycin® 4 and 9 parts grain carrier is the suggested working intermediate preblend. The table below shows Flavomycin® 4 and working intermediate preblend addition levels for various commonly used feeds: | |||||
Feed | Bambermycins in Type C Medicated Feed (g/ton) | Pounds Flavomycin® 4 per Ton Type C Medicated Feed | Pounds 1-9 Intermediate Preblend per Ton Type C Medicated Feed | ||
Broiler Chickens | 1 2 | .25 .50 | 2.50 5.00 | ||
Growing- Finishing Swine | 2 3 4 | .50 .75 1.00 | 5.00 7.50 10.00 | ||
Growing Turkeys | 1 2 | .25 .50 | 2.50 5.00 | ||
Thoroughly mix both working intermediate preblend and finished Type C medicated feed to ensure complete and uniform distribution of the Flavomycin® 4. | |||||
FEEDING DIRECTIONS: Type C medicated feed containing Flavomycin® 4 should be fed continuously as the sole ration. | |||||
Huvepharma®
Approved by FDA under NADA #044-759
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 23243-2060-5 | Flavomycin | 22.68 kg in 1 BAG | POWDER | 22.68 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 23243-2060 | FLAVOMYCIN (BAMBERMYCINS TYPE A MEDICATED ARTICLE) POWDER [HUVEPHARMA, INC.] | 8 | 1 package rows | 20240515_226e3192-984d-4ff0-9e65-c1e54a78e522.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BAMBERMYCINS | ACTIVE INGREDIENT | PP922A42V2 | 2 | |
| BAMBERMYCINS | ACTIVE MOIETY | PP922A42V2 | 2 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 2 |
Products#
Every source-derived product name is available through these pages.
- Flavomycin
- bambermycins Type A medicated article
- BAMBERMYCINS
- MINERAL OIL
- CALCIUM CARBONATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 23243-2060 | 23243-2060-5 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BAMBERMYCINS | PP922A42V2 | ACTIB |
| MINERAL OIL | T5L8T28FGP | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, COATED / ORAL | 64.8 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | GUM, CHEWING / BUCCAL | 3492 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, CHEWABLE / ORAL | 1650 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET / ORAL | 793 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, EXTENDED RELEASE / ORAL | 229.7 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE / ORAL | 349.9 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, DELAYED RELEASE / ORAL | 8.4 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE, DELAYED RELEASE / ORAL | 20 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / RESPIRATORY (INHALATION) | 4.02 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / INTRAVENOUS | 4.02 %w/v | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, FILM COATED / ORAL | 300 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / AURICULAR (OTIC) | 0.38 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | FILM, SOLUBLE / ORAL | 14 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | CAPSULE, EXTENDED RELEASE / ORAL | 4 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | POWDER, DENTIFRICE / DENTAL | 0.5 mg/mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
