Animal NDC 66104-8816-0 Bloat Guard
Poloxalene
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 66104-8816-0 |
| Proprietary Name | Bloat Guard What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| Non-Proprietary Name | Poloxalene What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| Labeler Name | Phibro Animal Health |
| Product Type | Otc Type A Medicated Article Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Inactive Ingredient(s) |
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| Marketing Category | NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| FDA Application Number | NADA038281 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
Bloat Guard Images
Bloat Guard Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Other
For use in the manufacture of liquid feed supplements
For control of legume (alfalfa, clover) and wheat pasture bloat in cattle
Not For Human Use
Restricted Drug (California) – Use Only As Directed
Net Weight 450 lb (204.12 kg)
Bloat Guard is a registered trademark of Phibro Animal Health Corporation for poloxalene
Phibro Animal Health, Inc., Teaneck, NJ 07666
Approved by FDA under NADA #038-281
8816000
101-8031-07
Active Drug Ingredient
Poloxalene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99.5%
Inert Ingredients:
Ethoxyquin (a preservative), 0.12%;
butylated hydroxytoluene (a preservative), 0.38%
Directions For Use In Liquid Feeds
Bloat Guard Liquid Type A Medicated Article must be thoroughly blended and evenly distributed into a liquid feed supplement and offered to cattle in a covered liquid feed supplement feeder with lick wheels. The formula for the liquid feed supplement is as follows:
For control of legume (alfalfa, clover, and wheat pasture bloat in cattle…7.5 g/lb | %w/w | For control of legume (alfalfa, clover) bloat in cattle grazing pre-bloom legumes…10.0 g/lb | % w/w |
Poloxalene Type A Medicated Article (99.5%) | 1.65 | Poloxalene Type A Medicated Article (99.5%) | 2.2 |
Ammonium Polyphosphate | 2.66 | Ammonium Polyphosphate | 2.66 |
Phosphoric Acid | 3.37 | Phosphoric Acid | 3.37 |
Sulfuric Acid | 1.00 | Sulfuric Acid | 1.00 |
Water | 10.00 | Water | 10.00 |
Molasses, liquid – sufficient to make | 100.00 | Molasses, liquid – sufficient to make | 100.00 |
Vitamins A&D and/or trace minerals may be added. | Vitamins A&D and/or trace minerals may be added. | ||
The concentration of Bloat Guard per lb of liquid feed supplement is as follows:
Indications for Use | Required Level of Bloat Guard |
For control of legume (alfalfa, clover) and wheat pasture bloat in cattle For control of legume (alfalfa, clover) bloat in cattle grazing pre-bloom legumes | 7.5 g/lb (1.65% w/w) 10.0 g/lb (2.2% w/w) |
Important:
To maintain proper distribution of Bloat Guard in liquid feed supplements, the viscosity of the medicated liquid supplement must be no less than 275 cps. During storage the medicated liquid may separate out of liquid supplements within 5 days if not agitated. It is essential that all of the stored mixture be thoroughly remixed (for example, by using a recirculating pump) before being transferred to feeders with free-turning lick wheels. Movement of the lick wheels is sufficient to prevent separation in the feeders.
Feeding and Management Directions for Bloat Guard
These medicated supplements are effective for the control of legume (alfalfa, clover) and wheat pasture bloat in cattle, when consumed as recommended.
• Use a covered liquid feeder with 1 free-turning lick wheel per 25 head at a height so that all cattle can conveniently lick the wheel.• The location of the liquid feeder is extremely important for adequate consumption. Place feeder where cattle congregate (for example, near drinking water), thus providing ready access to the medicated liquid feed supplement. In large pastures, additional feeders should be placed so that cattle are never more than 500 feet from a feeder while grazing.• For adequate protection, it is essential that each animal consumes the total recommended dosage of medication daily.• If grazing on pre-bloom legumes, use a liquid feed supplement containing 10 g of Bloat Guard per lb (2.2% w/w). Each animal must consume the medicated liquid feed supplement at a rate of 0.15 lb per 100 lb of body weight per day for adequate protection. Example: 1.5 lb of 2.2% medicated supplement for a 1000-lb animal daily. If consumption exceeds 0.2 lb per 100 lb of body weight per day, cattle should be changed to a liquid feed supplement containing 7.5 g of Bloat Guard per lb (1.65% w/w).• If grazing legumes or wheat pasture, use a liquid feed supplement containing 7.5 g of Bloat Guard per lb (1.65% w/w). Each animal must consume the medicated liquid feed supplement at a rate of 0.2 lb per 100 lb of body weight per day for adequate protection. Example: 2 lb of the 1.65% medicated supplement for a 1000-lb animal daily.• Introduce the feeding of the medicated liquid feed supplement at least 2-5 days before pasturing on legume or wheat to accustom the cattle to the medicated liquid supplement and to lick wheel feeding. If the medicated liquid feed supplement feeding is interrupted, this 2-5 day introductory feeding should be repeated.
Cold Weather Note:
At temperatures below 50°F, this product will thicken and may appear cloudy, but is not damaged.
Keep Container Closed When Not In Use
Store At Or Below 25°C (77°F), Excursions Permitted Up To 40°C (104°F)
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.