Animal NDC 66104-2301-0 Bloat Guard
Poloxalene

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-2301-0
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
    For use in the manufacture of feedFor prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle
Active Ingredient(s)
  • Poloxalene
Inactive Ingredient(s)
  • BUTYLATED HYDROXYTOLUENE (1P9D0Z171K)
  • ETHOXYQUIN (9T1410R4OR)
  • BUTYLATED HYDROXYTOLUENE (1P9D0Z171K)
  • ETHOXYQUIN (9T1410R4OR)
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 NADA032704 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



Indications & Usage



For use in the manufacture of feed

For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle


Active Ingredient



Poloxalene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53%

(Equivalent to 240 g/lb)

Inert Ingredients:

Ethoxyquin (a preservative), 0.064%; butylated hydroxytoluene (a preservative), 0.20%; Verxite ® (nonnutritive), approximately 47%


Caution:



For use in manufacturing medicated animal feeds only.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.


Store At Room Temperature



 


Mixing Directions



Bloat Guard Type A Medicated Article must be thoroughly and evenly distributed into feedstuffs. A mixture of Bloat Guard and 1 common feed ingredient should be made before final mixing when less than 25 lb of Bloat Guard is to be blended into a ton of feed.

Possible Mixing Ratios

Each lb of Bloat Guard contains 240 g of poloxalene, the active drug ingredient. The following table illustrates various amounts of Bloat Guard which may be added to feeds. The resulting concentration of poloxalene is also shown.

lb of Bloat Guard per ton of Type C Medicated Feed

g of poloxalene per lb of Type C Medicated Feed

% w/w of poloxalene in Type C Medicated Feed

8.3 lb

16.6 lb

33.2 lb

50.0 lb

83.3 lb

100.0 lb

208.3 lb

416.6 lb

625.0 lb

833.3 lb

1

2

4

6

10

12

25

50

75

100

0.22

0.44

0.88

1.32

2.20

2.64

5.50

11.00

16.50

22.00

For example: 50 lb of Bloat Guard, when added to 1 ton of feed, results in a final concentration of 6 g poloxalene per lb of Type C Medicated Feed (1.32% by weight).

Feeding Directions

The dosage of Bloat Guard is proportional to body weight and also depends upon the severity of the bloat-producing conditions. The normal dosage of Bloat Guard (1 g of poloxalene per 100 lb of body weight) is recommended for cattle under moderate bloat-producing conditions. For cattle under severe bloat-producing conditions, the normal dosage should be doubled (2 g of poloxalene per 100 lb of body weight).

Repeat the feeding of Bloat Guard when animals are exposed to bloat-producing conditions more than 12 hours from the last feeding of Bloat Guard, but do not exceed the double dosage of Bloat Guard in any 24-hour period. Animals should be fed the recommended amounts of Bloat Guard starting 2 or 3 days before they are exposed to bloat-producing conditions.

Caution: It is essential that each animal consumes the total recommended dosage of Bloat Guard daily for adequate protection.


Warning:



The normal life of this product is at least 24 months. However, when the product is subjected to extreme temperatures (38°C/100°F) for long periods of time (6 months), spontaneous combustion may occur. The product is not combustible unless it develops a strong, irritating odor; if this occurs, flush with water and discard immediately.

.

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED


Other



Follow Directions on Back Panel

Bloat Guard® is a Phibro Animal Health registered trademark for Poloxalene

Phibro Animal Health, Inc., Ridgefield Park, NJ 07660.

Net Weight 50 lb (22.7 kg)

Approved by FDA under NADA #032-704

8818000

101-9029-09

Verxite® is a registered trademark of W.R. Grace & Company


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.